Amelia Barbosa

Coroner's concerns

AI summary

Inadequate training means midwives still take inaccurate cord blood samples, leading to false reassurances. There is also a lack of training on UVC/IO access and blood transfusions for neonatal resuscitation.

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1. While I heard evidence that there has been training for Midwives on how to take cord blood, and I was provided with a copy of a poster that was said to have been in use at the Trust for some time, in April 2023, over 2 years after this delivery, the Midwife gave evidence that she and her colleagues were of the opinion that it was appropriate to take a sample from anywhere in the cord, not just in the clamped area. The expert and the Trust’s own Head of Midwifery advised that this was not appropriate. It therefore does not appear that the learning has been passed on to all Trust Midwives and there is a risk that in future cases those treating the baby will be falsely reassured by normal cord pH results which may not be accurate.

2. While I read evidence of some training that had been provided in response to HSIB recommendations for further training on auscultation in addition to saturation monitoring and ECG monitoring during resuscitation, the independent expert also recommended training on UVC and IO access. I am also concerned that there does not appear to have been training in relation to the provision of blood transfusions in such cases to ensure that all potential reversible causes are treated before resuscitation stops. The Head of Midwifery who attended the inquest to advise on issues relating to the recommendations was not in a position to provide evidence on the neonatal position and I have been provided with no evidence by the Trust that these issues have been considered. I am concerned that they require further action.

Responses

2 respondents

Product Safety Standards Other

15 Jun 2023 PDF

Action Planned

OPSS will assess the safety and compliance of similar baby bath seat models and work with the Baby Products Association to remind members of safety requirements. They will also ask the NHS to consider including safety messages related to baby bath seats in their communications. (AI summary)

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Dear Miss Kirsty Gomersal,

Thank you for your Regulation 28 Report (Prevention of Future Deaths) dated 20 April 2023, following your investigation and inquest into the death of Chester Allan Stanley Mossop.

First, I would like to say how deeply saddened I was on hearing of the tragic death of baby Chester. I would be grateful if you could pass on my condolences to the family if you have the opportunity to do so.

The Office for Product Safety and Standards (OPSS) is the UK’s national product regulator. The UK has a product safety system designed to provide a high level of protection for consumers and all consumer products including baby bath seats, must be safe before they can be sold on the UK market. The safety of baby products is a priority area for OPSS and we have recently taken action to prevent the sale of a number of unsafe baby products including baby self-feeding devices.

Baby bath seats are regulated under the General Product Safety Regulation 2005 (GPSR). This places an obligation on manufacturers or importers to ensure their products are safe before they can be placed on the market (Regulation 5 of GPSR). They must also provide safety information to enable consumers to assess risks that are not immediately obvious without adequate warnings and to take precautions against those risks (Regulation 7 of GPSR). Distributors have a separate duty to act with due care to ensure that products they offer for sale comply with the law; are safe; and to pass on the necessary information on the risks posed by the product (Regulation 8 of GPSR).

The Office for Product Safety and Standards is part of the Department for Business and Trade. We strive to enhance protections for consumers and the environment and drive increased productivity, growth and business confidence.

Since receiving your Report, OPSS has been in contact with your office to obtain further details of the product involved in this incident. As a result, OPSS will be assessing the safety and compliance for similar models of baby bath seat to assess their compliance with legal requirements. While we do not currently have any evidence that the product itself is unsafe or non-compliant, should that be identified, we have a range of actions open to us to ensure products are brought into compliance or removed from the market.

We will also work with the Baby Products Association (BPA), the relevant trade association for the sector, to ask them to remind their members of the requirements for including appropriate instructions for safe use and to ensure that any safety warnings for baby bath seats are suitably clear and prominent. We have worked closely with the National Health Service (NHS) on our programme of activity on the safety of baby products and will ask them to consider whether there is an opportunity to include safety messages related to baby bath seats through their communications with healthcare professionals and new parents.

Thank you again for bringing this tragic case to our attention.

North West Anglia NHS Foundation Trust NHS / Health Body

4 Jul 2023 PDF

Action Taken

Following the inquest, the midwifery department has produced and issued a poster clarifying that cord blood samples must be taken from the clamped area and the neonatal resuscitation trolley is now routinely stocked with short intraosseous needles. (AI summary)

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Dear Ms Goward Inquest relating to the death of Amelia BARBOSA I refer to your Regulation 28 Report dated 19th May issued following the inquest. There were two matters of concern which you have asked the Trust to respond to. The first area of concern relates to the taking of cord blood samples by midwifery staff. You heard evidence at the inquest that the midwife in this .case did indeed attempt to take a sample of blood from that part of the umbilical cord which had been clamped. Unfortunately, she was unable to obtain any blood from there and therefore obtained a sample from the unclamped part of the cord. Following the inquest the midwifery department has produced and issued a poster in relation to this. I have enclosed a copy of the poster which makes it clear that cord blood samples must be taken from the clamped area and not from any other part of the cord or placenta. If the midwife is unable to obtain any blood from this part of the cord then they are to inform the Paediatricians in order that they can take a capillary sample. The second area of the concern relates to the attempts to resuscitate after Amelia had been delivered in a very poor condition. An experienced Paediatric Registrar was in charge of the resuscitation until the Consultant Paediatrician arrived. The Registrar was unable to insert an umbilical vein catheter (UVC) in order to administer drugs and fluids. He therefore attempted intraosseous access. However, as only long intraosseous needles were available in theatre there was a delay whilst short intraosseous needles were located. I can confirm that following this incident the neonatal resuscitation trolley is now routinely stocked with short intraosseous needles. As for UVC insertion, this is a technically difficult skill and UVCs are only inserted by Paediatric Registrars and Consultant Paediatricians. Before a

Paediatric Registrar can be signed off they must be able to insert UVCs under observation. However, as the independent expert stated during the inquest, there are occasions when it is simply not technically possible to insert a UVC. Hence the decision in this case to try to gain intraosseous access to give drugs and fluids. I can also confirm that there is regular training for undertaking these procedures on the ATLS (Advance Trauma Life Support) course which clinicians attend every four years. In addition, the Trust will be introducing annual updates for these procedures from September of this year for all doctors involved in looking after neonates. Your report also referred to training in relation to the provision of blood transfusions. Whether a blood transfusion is given during a resuscitation is a matter of clinical judgement for the clinician in charge of resuscitation. However, it has been accepted by our Paediatricians that there should be a low threshold for giving a blood transfusion. In particular, it is preferable to give a bolus with blood rather than fluids. This adopts the NLS (Newborn Life Support) Guidelines from 2021 which recommends this. I hope that our response to your report has provided reassurance to both you and the family that the necessary changes to our practice have been made following Amelia's tragic death. I would also like to take this opportunity on behalf of the Trust to reiterate our deep condolences for Amelia's parents.

Report sections

Investigation and inquest

On 14 October 2021 an investigation in to the death of Amelia Barbosa was commenced. Amelia died on 13 December 2020, aged 7 days. The investigation concluded at the end of the inquest on 17 May 2023. The conclusion of the inquest was: Medical Cause of Death – 1a Hypoxic Ischaemic Encepalopathy, 2 Placental pathologies: acute chorioamnionitis and delayed vilious maturation Conclusion – Died as a result of an acute hypoxic injury in the period immediately before delivery, and which continued during resuscitation, leading to hypoxic ischaemic encephalopathy.

Circumstances of the death

1. In summary, Amelia’s mother had a routine pregnancy and was given a due date of 01 December 2020. She attended Peterborough City Hospital at around 1030 hours on 5 December 2020.

2. From very early on, the CTG trace was classified as suspicious on a number of occasions and on some occasions as pathological. Evidence and a report from HSIB confirms that assessment and decision making during this period was appropriate.

3. Due to a failure to progress in the second stage of labour and suspected fetal compromise at around 0240 hours, a decision was made for a Category 2 Caesarean section delivery.

4. The CTG trace was stopped at 0404 hours to enable the Caesarean to take place.
5. As had been anticipated, there was some difficulty due to Amelia’s head being impacted, but the Obstetrician and senior Midwife worked together and this was resolved within 4 minutes.

6. Due to difficulties siting a spinal anaesthetic, and Amelia’s head being impacted, the time from decision to delivery was 83 minutes. Expert evidence confirmed that, on the balance of probabilities, Amelia suffered an acute hypoxic insult commencing around 10 minutes before her delivery and which was ongoing during resuscitation.

7. At delivery, no APGAR scores were recorded as they should have been. However, based upon the evidence in the notes, I accepted the hypothesis from HSIB that it is likely that her scores were 0 at 1 minute and 1 at 5 minutes.

8. The Midwife took cord blood gases but, as there was no blood in the clamped section of the cord, the blood was taken from a different part of the cord. I heard independent expert evidence from a Consultant Neonatologist that these are not likely to have been reliable as they were taken from close to the base of the placenta rather than the clamped section of cord.

9. The evidence of the Midwife at the inquest was that she felt, and she had since discussed this with colleagues who agreed, that if necessary it was fine to take blood from anywhere in the cord. Both the independent expert and the Trust’s own Head of Midwifery, who gave evidence on changes made at the Trust in light of HSIB recommendations, agreed that blood should not be taken from anywhere other than the clamped section of cord. Further, if that was not possible, it must be clearly communicated to the Neonatal/Paediatric team.

10. There were a number of issues identified with the resuscitation and concerns raised by both HSIB and the independent expert, some of which were addressed by the Trust who produced evidence to confirm how these issues had been resolved.

11. However, other issues were identified. One such issue was that the independent expert advised that resuscitation attempts should not have stopped until all reversible causes had been considered and treated. Prior to resuscitation stopping, no blood transfusion had been given. Amelia had been described to be very pale. Her haemoglobin level was later found to be 94. Both the expert and HSIB felt a transfusion should have been given. The treating Registrar also gave evidence that, had he been aware of the issue with the cord blood and another issue relating to the condition of the placenta, he would have given a transfusion. The treating Consultant who gave evidence however disagreed.

12. One of the recommendations from HSIB was for there to be training and feedback to those involved in this case, and others who were not, to learn lessons.

13. There was also difficulty inserting an umbilical venous catheter, which I accept can be difficult even in experienced hands, and the delay in intra osseous access, which was contributed to by the lack of correct equipment on the resus trolley, led to a delay in Amelia receiving adrenaline, fluid volume and sodium bicarbonate. The expert recommended that staff undergo training to improve their skills for obtaining UVC and IO access.

14. While in NICU there was also a delay in Amelia being effectively cooled due to the active cooling machine not working. I was advised that this has now been replaced.

15. Amelia was transferred to Addenbrooke’s Hospital where the extent of her injuries were confirmed and she sadly died on 13 December 2020.

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