Source · Prevention of Future Deaths

Joyce Tozer

Date: 15 Dec 2015 Coroner: Emma Brown Area: Birmingham and Solihull Responses identified: 1 / 1 View PDF

Omnipaque is frequently administered at doses exceeding manufacturer's guidelines, sometimes via central lines, which exposes interventional radiology patients to potential toxicity risks.

Date 15 Dec 2015
56-day deadline 10 Feb 2016
Responses identified 1 of 1
Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary
Omnipaque is frequently administered at doses exceeding manufacturer's guidelines, sometimes via central lines, which exposes interventional radiology patients to potential toxicity risks.
View full coroner's concerns
Consultant anaesthetist for the procedure on the 12th June 2015,gave evidence that since Mrs. Tozer'$ death, he has become concerned that the dose of 10Oml omnipaque record in the notes as being administered by the radiologist minutes before Tozer'$ sudden deterioration was well in excess of the dose recommended by the manufacturer of omnipaque (1ml/kg) especially as it was administered through & central line rather than peripheral venous access At this time Mrs Tozer' $ weight was 52kg) stated that he was concerned that the administration of a hypertonic solution at this dose into a central line may have affected Mrs. Tozer's heart rhythm although there was no way he could give an opinion as to whether it was the likely cause of her deterioration and death as the presentation of toxicity cannot be distinguished from an anaphylactoid reaction Igave evidence that having made enquiries about the dose with Lead Interventional Radiologist at the Trust, he has been told that a 10Oml dose is often used. am concerned that doses of omnipaque well in excess the and has during May line Mrs. being of the manufacturer' s guidelines are frequently administered, sometimes through central lines, and this practice could be exposing interventional radiology patients to risks from toxicity:

Responses

1 respondent
Joyce Tozer
8 Feb 2016 PDF
Disputed

University Hospitals Birmingham NHS Foundation Trust held a roundtable meeting which concluded that the deceased was administered 100ml of Visipaque (not Omnipaque), a standard dose within manufacturer's and literature guidelines. They dispute that an overdose occurred, stating the radiographer acted appropriately and the death was likely due to a rare allergic reaction rather than toxicity. (AI summary)

View full response
Dear Madam

Joyce Beatrice Tozer (deceased)

In response to the Report to Prevent Further Deaths issued by you on 15 December 2015, following the inquest in to the death of the above, I am writing to inform you that this Trust has taken action as follows:

A round table meeting was held on 24th December to discuss whether an overdose was a causative factor in the death of the deceased. The roundtable review noted that the deceased had become unwell following administration of 100ml Visipaque (Omnipaque was incorrectly documented in the medical notes, the correct contrast agent is recorded on the Trust's imaging system. 100mls is considered to be a standard dose; Visipaque is iso-osmolar and therefore theoretically less toxic than Omnipaque).

The Trust's protocols regarding the administration of intravenous contrast agents were considered, together with the manufacturer's guidelines for administering Visipaque and available literature relating to similar use. The review found that:

1. The radiographer administering the contrast acted entirely appropriately and within the limitations of the expanded practice IV protocol;

2. The contrast dose administered to the deceased was not outside of the manufacturer's range or that of the literature for this technique; and

3. When carrying out interventions with contrast media, there are occasions when the recommended dose (per unit body weight) is exceeded. However, this is not undertaken without an assessment against the risk of not obtaining adequate images of the relevant body part and the inherent risk to the patient in not completing the intervention.

Chair: Rt Hon Jacqui Smith Chief Executive: Dame Julie Moore Page 1

The review concluded that there was not an overdose and that it is probable that the deceased died of a rare allergic reaction to the Visipaque, and not from the toxicity of the agent.

I trust the action taken will provide you with assurance that doses of contrast in excess of manufacturer's guidelines are not frequently administered in this Trust and that, therefore, patients are not exposed to risks from toxicity.

If you require any further information please do not hesitate to contact:

[Redacted] 0121 371 4317 Director of Corporate Affairs

Report sections

Investigation and inquest
On 26th June 2015 commenced an investigation into the death of Joyce Beatrice TOZER: The investigation concluded at the end of the inquest &th December 2015_ The conclusion of the inquest was that the deceased passed away at the Queen Elizabeth Hospital Birmingham on the 12th June 2015 as a result of a reaction to contrast material injected during an interventional radiology procedure to insert bilateral nephrostomies. not been possible to determine whether the reaction was due to an allergic response or a response to the toxicity of the 1OOml dose of omnipaque contrast solution given The need for bilateral nephrostomies was to manage urinary leak from a conduit anastomosis placed radical surgery on the 27th 2015 to treat recurrent anal cancer; The medical cause of death was: 1(a) Reaction to the administration of ominpaque contrast solution 2 Recent Surgeries for the treatment and management of anal cancer.
Circumstances of the death
As a consequence of urostomy leakage following surgery on the 27th May 2015 Mrs. Tozer required bilateral nephrostomies. During the interventional radiology procedure to place the nephrostomies on the 12th June 2015 Mrs. Tozer remained stable until minutes after the injection through her central ofa 10Oml dose of omnipaque at which time her condition deteriorated dramatically leading to cardiac arrest from which she could not be resuscitated.
Action should be taken
In my opinion action should be taken to prevent future deaths and believe you have the power to take such action

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Report details

Date of report
15 December 2015
Coroner
Emma Brown
Coroner area
Birmingham and Solihull

Responses identified

Responses identified 1 of 1
All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 10 Feb 2016.

Sent to

University Hospitals Birmingham NHS Foundation Trust

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