University Hospitals of Liverpool Group

7. Miss M complains about aspects of care and treatment provided to her by the Trust from July 2020 to February 2021.

8. Miss M says the Trust: • has failed to uphold its duty of candour and did not clearly explain the events that led to her health deteriorating and her being placed in a coma during its investigation of this complaint • incorrectly told her she had a diagnosis of vasculitis and this caused the sudden deterioration in her condition • gave Miss M too much enoxaparin, and adrenaline through a cannula which is against guidelines • has failed to uphold a good standard of record keeping.

9. Miss M says she has not been able to get answers to her questions due to the poor record keeping, poor complaint handling, and lack of duty of candour. For six months she was led to believe she had an autoimmune disease which left her in a state of worry that she might deteriorate again.

10. Miss M also says she and her family have been left distraught as they thought she was going to die. She has been diagnosed with anxiety, depression and complex post-traumatic stress disorder (CPTSD). Miss M has attended counselling following the events in July 2020 and feels she has lost three years of her life.

11. Miss M is seeking acknowledgement, a sincere apology, service improvements and a financial remedy.

12. This brief background is to place the key events in context, not provide a full account of everything that happened.

13. On 24 July 2020, Miss M was prescribed an antibiotic to treat a urine infection.

14. On 28 July, she went to the Trust’s emergency department (ED) with symptoms of an allergic reaction. The Trust treated her for this and kept her in overnight. It discharged her home the following day with medication.

15. On 30 July, Miss M returned to the Trust with ongoing symptoms of an allergic reaction. She told us she was in a cubicle in the ED when a nurse gave her medication through her cannula at around 12.15pm.

16. She developed chest pain, difficulty breathing and coughed up blood. She needed a breathing tube and machine to help her breathe. Staff transferred her to the ICU, where she stayed for four days.

17. At the time of her deterioration, it was unclear what had caused her illness. Staff investigated and treated her for multiple conditions. When the Trust discharged her, doctors thought the most likely cause of her illness was vasculitis.

18. In February 2021, the Trust’s vasculitis nurse practitioner told Miss M she did not have vasculitis. She has not received another explanation for the episode on 30 July 2020.

Adrenaline

22. Miss M attended ED on 30 July 2020 as she had a rash. Her medical records indicate she arrived at ED at 11.34am and staff triaged her for a senior doctor review.

23. Miss M told us that at 12.15, she was in a cubicle and a nurse entered. She says the nurse attached her to monitoring equipment and advised her she would give her some adrenaline which may make her shake a little bit. Miss M reports the nurse injected medication into her cannula.

24. She says her muscles went into spasm, and she fell to the right side of the bed. She recalls her chest feeling like it was going to explode and a sense of impending doom. She recalls seeing the heart monitor reach 220 beats per minute (bpm). She says the nurses called for help and other staff ran in and placed an oxygen mask on her.

25. We have seen messages Miss M sent to her mother at the time. At 12.33, she sent a message stating ‘mum I’ve just nearly died’ with a picture of her wearing an oxygen mask. At 12.44, her mum asked ‘too much adrenaline?’, and at 12.48 Miss M replied saying ‘whatever they give me did not agree with me’.

26. At 12.15, Miss M’s drug chart shows a prescription of 0.5mg adrenaline to be given intramuscularly (IM). There are signatures in both the ‘given by’ and ‘checked by’ boxes.

27. This indicates a member of staff checked the drug and another member of staff administered it. In the box for ‘time given’, it states 12.16. This prescription then has a line through it, with a note stating, ‘not given’. There is no date or time for this note.

28. There are no corresponding notes by clinical staff indicating why someone crossed out the entry, or any further explanation. The Trust has been unable to find any further information around this entry.

29. At 2.09pm, a doctor entered notes retrospectively regarding seeing Miss M at 12.17. They reported she had throat swelling and a rash and, upon assessing her, that she complained of chest pain and looked pale. They noted she was in SVT (Supraventricular tachycardia- an abnormally fast heartbeat) with a heart rate of 180-200bpm.

30. The doctor documented Miss M had eight episodes of SVT that lasted one to two minutes and resolved by themselves. They documented a diagnosis of anaphylaxis (life-threatening allergic reaction) and SVT. There is no documented plan to prescribe adrenaline.

31. At 5.03pm, the ED consultant documented she had been given treatment for anaphylaxis. It is not clear if this meant adrenaline, nor the time it was referring to.

32. Adrenaline affects the nervous system to trigger a ‘fight or flight’ response. Its action results in fast heart rate, high blood pressure, trembling, dizziness and chest pain.

33. The BNF explains intramuscular (IM) adrenaline is used to treat anaphylaxis at a dose of 0.5mg. If intravenous (IV) adrenaline is used in anaphylaxis, a far lower dose is provided, by specialists with appropriate monitoring, and only if there has been no response to IM adrenaline first.

34. Our ED adviser explained Miss M’s reported symptoms of a high heart rate, chest pain, sense of doom and muscle spasms could be caused by either IV or IM adrenaline. IV administration would cause more intense symptoms than IM.

35. Our ED adviser explained IM or IV adrenaline could cause a fast heart rate and SVT. They explained Miss M’s episodes of SVT would account for her chest pain and high heart rate. As they were resolving without intervention, they said they would be unlikely to account for all her symptoms and her subsequent deterioration.

36. Miss M’s drug chart shows she received two other medications through her cannula. She had ondansetron (anti-sickness) at 12.24pm, and ranitidine (for reflux and allergy) at 12.30pm. The BNF indicates neither of these drugs would cause the symptoms she described. She received them after she reported feeling unwell.

37. We considered all the available evidence to determine if we can make a decision on the balance of probabilities of what happened in the ED on 30 July.

38. Miss M has provided a comprehensive account of her symptoms, with timings and supporting evidence of contacting her family when she deteriorated. She first raised these concerns at a hospital appointment in October 2020. Her account has remained consistent since.

39. Her medical records contain a drug chart that indicates adrenaline was prescribed at 12.15 and given at 12.16pm. The Trust has not been able to provide an explanation for why this was checked and signed for and then crossed out.

40. Our ED adviser has confirmed the symptoms Miss M experienced could be in keeping with the administration of IM or IV adrenaline. Miss M is clear the medication she received was through her cannula. She had received IM adrenaline on 28 July so had recent experience of what that felt like. We do not consider other medications could have caused her symptoms.

41. As per the BNF guidance in paragraph 33, ED staff should not give IV adrenaline in the first instance for anaphylaxis, or without specialist oversight and appropriate monitoring.

42. Taking all the above into account, we have found, on the balance of probabilities, the Trust gave Miss M IV adrenaline against relevant guidance on 30 July 2020. We will consider the impact later in this report.

Enoxaparin

43. At 3.15pm on 30 July, a doctor prescribed Miss M enoxaparin as they suspected a Pulmonary Embolism (PE- a blood clot in the lungs).

44. They intended to prescribe a dose of 1mg/kg but prescribed a dose of 2mg/kg by mistake. Because of this, Miss M received 100mg of enoxaparin at 3.30pm. The doctor noted the error at 5.06pm and they completed an incident reporting form.

45. The BNF states the correct dose of this is 1 – 1.5mg/kg. The Trust made an error in giving her a larger than intended dose. It documented this error in her records and completed an incident report.

46. We agree with the Trust that it prescribed a dose of enoxaparin out of the range advised in the BNF.

47. It is unclear exactly when Miss M started coughing up blood, but both her recollection and the nursing notes indicate it was before the Trust gave her enoxaparin.

48. Our ED adviser explained the Trust was correct to prescribe enoxaparin as it was considering a PE as a cause of her symptoms. Coughing up blood can be a symptom of this. She later had scans that showed she did not have a PE.

49. Our ED and ICU advisers explained it would be difficult to define the impact of this drug error. It did not cause her bleed, but it is possible this overdose of a blood thinner worsened the haemorrhage. We would not be able to define the exact increase in risk from this drug. We recognise learning about this error would have caused Miss M distress.

50. As a result of this error, the Trust created an action plan to learn from the mistake. This included education on enoxaparin prescribing to be covered by induction programmes, and for educational posters to be placed in ED. We will consider later in this report further actions it could take.

Vasculitis

51. When the Trust admitted Miss M to ICU, staff were not sure what had caused her illness but treated each potential condition. One of these conditions was vasculitis. Staff sent multiple blood tests off and gave Miss M steroid treatment. We recognise the ICU staff may have been unaware of the events in the ED.

52. By the time Miss M left ICU, her blood tests ruled out many possible causes of vasculitis. Doctors thought it might have caused her illness, but they could not confirm it. Her clinic letters after follow-up visits show vasculitis was never definitively diagnosed, and the exact cause of her illness remained unclear.

53. We have found the Trust administered IV adrenaline and failed to be open about this. We consider this led to her illness and ICU admission. Therefore, the Trust was incorrect to diagnose Miss M with vasculitis and tell her this was the reason she had become unwell. We will address the impact of this diagnosis later in this report.

Record keeping

54. GMC and NMC guidance say doctors and nurses must make clear and accurate records. These should be made at the same time as events they are recording, or as soon as possible afterwards.

55. We reviewed Miss M’s medical records from 30 July. Between a doctor review carried out at 12.17 (but recorded at 2.09pm), and 3.14pm, there are no nursing or medical entries. We recognise staff often write entries in retrospect when clinical need takes priority.

56. The ED patient safety checklists say staff took observations at 12pm and 2.30pm. Miss M had a recorded heart rate of 180-200bpm at 12.17 and ECGs at 1.46 and 1.49pm showing heart rates of 131-134bpm. These would have given her a NEWS score of 3, requiring one-hourly observations in line with RCP guidance. There are no corresponding observation charts, so these charts were either not completed or are missing.

57. RPS guidance says when staff do not give prescribed medication, they should record the details of the reason why. If they cannot amend the drug chart, staff should update the patient records. The ‘not given’ entry on the adrenaline prescription is not timed, signed or annotated with a reason why. There are no corresponding records to explain.

58. It is unclear when staff moved Miss M to Resus. There are conflicting times on monitoring charts, the Trust’s complaint response and nursing notes. When staff have entered records in retrospect, they have not always stated the time the events happened.

59. Given Miss M’s deterioration between 12.17 and 3.14pm, our ED adviser explained they would have expected more documentation. The Trust has confirmed it has shared all available records with us.

60. We do not know why her records are lacking as the Trust was unable to identify what happened. We understand it has checked for physical copies of records and interrogated systems to see if it has lost records. The Trust has been unable to provide any further explanations to Miss M or to us.

61. We have found the Trust has not acted in line with GMC, NMC or RPS guidance with regards to record keeping. We will consider the impact of this later in our report.

Complaint investigation and Duty of Candour

62. Miss M raised complaints with the Trust between January 2021 and March 2023. She asked it to investigate the medication that made her unwell between 12.10pm and 12.32pm, and specifically if it had given her adrenaline.

63. The Trust’s responses contained information that did not match her medical records. It has not carried out any investigation into Miss M’s specific complaint about the medication at 12.15pm and failed to mention the presence of adrenaline on her prescription chart.

64. Miss M recalled the first names of nurses involved. The Trust was unable to identify them. It told us it could not identify the signatures on the prescription chart or obtain a staff rota for that day. It has been unable to explain the reasons these were not possible. Its first response said it had spoken to staff involved, but it has no written evidence of this.

65. Staff did not tell Miss M’s family about the enoxaparin prescription error when it occurred, indicating a failure to be open at the time of the event. The Trust could not explain why in its response.

66. It did not answer Miss M when she raised further concerns about its response and her incomplete records.

67. Our NHS complaint standards say organisations should ‘give a clear, balanced account of what happened based on established facts.’ They say staff should ‘explain why things went wrong and identify suitable ways to put things right for people.’

68. On reviewing the investigation report and complaint responses, we have found the Trust has not met these standards.

69. Duty of Candour regulations say organisations must act in an open and transparent way in relation to care and treatment provided. A notifiable safety incident is any unintended incident that could result in the death or severe, moderate or prolonged psychological harm to the patient.

70. When a notifiable safety incident occurs, organisations must tell the person involved face to face, apologise, provide a true account of what happened, investigate, follow up in writing and keep a record of these conversations. The regulations say if the incident was not realised at the time, but discovered later, the duty still applies.

71. Certain incidents need to be reported to the Care Quality Commission (CQC), which is the regulator. The CQC guidance sets out how organisations should comply with their duty of candour obligations under the regulations.

72. The joint GMC and NMC guidance say when something goes wrong, it is crucial this is reported at an early stage so lessons can be learnt quickly, and patients can be protected from harm.

73. We have found the Trust’s actions caused prolonged psychological harm to Miss M. As the Trust did not thoroughly investigate Miss M’s concerns, it did not identify what happened. It did not consider its obligations in line with the Duty of Candour regulations, CQC, and joint GMC and NMC guidance. Our findings in terms of the Trust’s lack of compliance with the Duty of Candour apply to both the point at which it gave Miss M adrenaline, and also during its investigation of the complaint. We will consider the impact later in this report.

Impact

74. The NHS website describes Takotsubo cardiomyopathy (TC), also known as Broken-heart syndrome. It is a temporary heart problem caused by significant emotional or physical stress, linked to a surge in adrenaline. Our ICU adviser signposted us to the case reports listed above where IV adrenaline can also trigger TC.

75. TC suddenly weakens the heart muscle, particularly affecting the left ventricle (LV- a chamber of the heart responsible for pumping blood around the body). LV failure can cause fluid in the lungs (pulmonary oedema) making it difficult to breathe.

76. Cardiomyopathy UK explains the symptoms can include sudden, intense chest pain, shortness of breath, and abnormal heart rhythms. It can cause elevated markers of heart damage on blood tests, which Miss M had.

77. Echocardiograms (scans of her heart) on 30 and 31 July showed severe LV dysfunction. On 7 August, a cardiac MRI (a different type of scan) showed fluid and mild LV dysfunction. Her follow up Echo in October 2020 was back to normal. Our ICU adviser explained this rapid, severe deterioration in a young healthy person, followed by a swift improvement and return to normal, is in keeping with the literature on TC.

78. Our ICU adviser explained adrenaline can also have a direct effect on blood vessels in the lungs. This causes increased pressure that can force fluid into the lungs. This pressure can also cause damage to the Mr between the blood vessels and small airways. This leads to blood in the lungs (pulmonary haemorrhage).

79. A bronchoscopy (camera examination of the airways) on 31 July found no specific bleeding point. Our ICU adviser explained this suggests her lung bleeding was caused by small blood vessel and airway damage.

80. When she was intubated (a tube inserted to help her breathe), the anaesthetist noted she had a mix of bright red blood, which indicates pulmonary haemorrhage, and frothy sputum, which indicates pulmonary oedema. Our ICU adviser said it therefore seems she had a mix of the two, both of which can be explained by the administration of IV adrenaline.

81. The fluid and blood in her lungs caused her to have difficulty breathing and her oxygen saturations to drop. These led to her needing to be intubated and ventilated (attached to a breathing machine) and transferred to ICU.

82. Our ICU adviser said adrenaline’s effects were the most likely explanation for her deterioration.

83. Between August 2020 and August 2021, Miss M required multiple hospital visits and tests, to try to identify the cause of her deterioration, and to ensure she had no ongoing physical harm. She was on steroids for six months as a treatment for vasculitis, which she told us caused her significant side effects. These included headaches, gastrointestinal disturbances, muscle weakness and joint pain. She was very anxious about her illness returning.

84. Miss M delayed starting university in September 2020. She told us she needed exposure therapy to attend hospital placements in her physiotherapy degree. This is a type of therapy that helps people manage their fears with safe, gradual exposure to them. She also needs to avoid placements in the ICU.

85. We have seen in her GP and counselling records that she has struggled with day-to-day activities due to flashbacks, nightmares, insomnia and emetophobia (fear of vomiting). She was diagnosed with PTSD, mixed anxiety and depression, and suffered from panic attacks.

86. During Cognitive Behavioural Therapy, Miss M described to her counsellor the feeling of suffocating and drowning as she struggled to breathe. She recalls feeling scared, confused and that she was about to die.

87. Miss M told us she can only compare herself to who she was before the incident. She says she was independent, lively, active, intelligent, happy, spontaneous, and bubbly. Now, she feels like a shell of that person, and often grieves the life she once had. Miss M’s father told us it has been difficult for the family to witness the effects of what happened to Miss M.

88. Post-traumatic stress disorder following an ICU admission is well-recognised. The Faculty of Intensive Care Medicine says these symptoms do not get better over time and can get worse. It can have a very negative impact on quality of life. It advises expert psychological therapy to help patients affected to move on with their lives.

89. Since her discharge from the Trust, Miss M has worked with counsellors on her psychological wellbeing and has required medication from her GP to assist with anxiety and insomnia.

90. Overall, we have found the impact of the Trust’s administration of IV adrenaline led to Miss M’s ICU admission. The diagnosis of vasculitis led to side effects from steroids. Both these failings led to her needing a year of medical appointments, delaying university, and a significant mental health impact which is ongoing.

91. We have found the impact of poor record keeping and investigation handling to have exacerbated her distress, by preventing Miss M from having a clear account of what happened to her. This has led to over five years of uncertainty and a lack of trust in the hospital. She has been unable to move on or seek the appropriate remedy.

92. We acknowledge that repeatedly revisiting her traumatic experience through this process has significantly added to her distress.

1. We are very sorry to hear of the circumstances of Miss M’s complaint. We can see the events of July 2020 significantly affected her. We thank her for her patience while we have carried out our investigation.

2. We have found failings with the Trust’s administration of adrenaline, a drug used to treat allergic reactions. We have considered this point on the balance of probabilities, and have found the Trust administered this drug into Miss M’s vein in error.

3. We have also found failings with the Trust’s administration of enoxaparin (a blood thinner), the diagnosis of vasculitis (a condition that causes inflammation of blood vessels), its record keeping and investigation handling.

4. The impact of the administration of adrenaline was Miss M becoming seriously unwell and needing an Intensive Care Unit (ICU) admission. This has led to a significant mental health impact including post-traumatic stress disorder (PTSD). The impact of the enoxaparin, vasculitis diagnosis, record keeping and investigation handling have added to and prolonged this emotional distress.

5. We uphold Miss M’s complaint.

6. We recommend the Trust provide acknowledgement of the failings to Miss M and apologise for the impact on her. We recommend it considers its obligations under Duty of Candour reporting and creates an action plan for service improvements. We also recommend it makes a payment of £8000 to Miss M in reflection of the impact.