The Trust failed to ensure her iron infusion was carried out safely
11. The Trust CosmoFer protocol says patients receiving CosmoFer should be monitored as follows:
• Take temperature, blood pressure (BP) and pulse before the infusion • For all infusions, give the test dose, stop the infusion and observe temperature, BP and pulse after 15 mins. If no adverse reaction, give the remaining infusion over 3 hours and 45 minutes • Monitor temperature, BP and pulse 30 mins after the infusion.
12. The records show at 8:45am on 4 August 2022, prior to the infusion, the Trust recorded Mrs P’s temperature, BP and pulse and noted no concerns. The records indicate her National Early Warning Score (NEWS, a system used to assess and track the condition of patients in hospital and help identify and respond to signs of deterioration) was recorded at 0 indicating she was deemed to be at low risk of a clinical deterioration.
13. The Trust then commenced a test dose of 25mg of CosmoFer at 9:00am. Our nurse adviser said the test dose is provided over 15 minutes and the Trust would then be expected to record Mrs P’s temperature, BP and pulse again 15 minutes after the test dose was given. However Mrs P became unwell during the test dose and the nursing team stopped the infusion at 9.05am.
14. Our nurse adviser said the records indicate the nursing team carried out appropriate checks and administered the infusion in line with the Trust CosmoFer protocol. Mrs P’s observations were normal prior to the infusion and there is no indication in the records the infusion should not have gone ahead.
15. Our nurse adviser said hypersensitivity reactions (abnormal immune responses) to iron infusions are possible even if the patient has had the treatment previously without any adverse effects. The records indicate this is what happened in Mrs Ps’ case as she had received her first dose without experiencing any adverse side effects on 4 July 2022. Our nurse adviser said such reactions cannot always be foreseen which is why a test dose is given first.
16. We carefully considered Mr F’s complaint and the supporting information he has provided. We also considered the information in the records, the Trust CosmoFer protocol and the advice we have received.
17. We found no evidence to indicate it was not appropriate for the Trust to proceed with the infusion on 4 August 2022. We found no evidence to indicate the Trust failed to carry out the appropriate checks before starting the infusion or ensure it was carried out safely. The Trust acted in line with its CosmoFer protocol and we found no evidence to indicate Mrs P’s reaction to the medication on this occasion could have been anticipated.
The Trust failed to provide the appropriate care and treatment after she became unwell during the infusion
18. The NMC code says nurses must:
• Accurately identify, observe and assess signs of normal or worsening physical and mental health in the person receiving care
• Make a timely referral to another practitioner when any action, care or treatment is required
• Ask for help from a suitably qualified and experienced professional to carry out any action or procedure that is beyond the limits of your competence.
19. The records indicate Mrs P started to feel unwell five minutes after the test dose was started. The nurses recorded her observations and noted a drop in her oxygen saturation level which had reduced to 86%. The nursing team provided Mrs P with oxygen therapy and her oxygen saturation level increased to 92%. The records indicate the nursing team called the Trust’s emergency team at 9:15am.
20. Our nurse adviser said the records indicate the nursing team started the test dose in line with the Trust’s CosmoFer protocol and promptly identified Mrs P’s deterioration when it happened. Our nurse adviser said the records indicate the nursing team provided initial treatment and then escalated Mrs P’s care to the Trust’s emergency team in line with the NMC code.
21. The RCUK guidance says emergency teams must:
• Use the Airway, Breathing, Circulation, Disability, Exposure (ABCDE) approach to assess and treat the patient
• Do a complete initial assessment and re-assess regularly
• Treat life-threatening problems before moving to the next part of assessment
• Assess the effects of treatment
• Recognise when you will need extra help and call for appropriate help early.
22. The RCUK guidance says the aim of the initial treatment is to keep the patient alive and, if possible, achieve some clinical improvement in order to allow for further treatment and making a diagnosis.
23. The GMC guidance states:
‘You must provide a good standard of care. If you assess, diagnose or treat patients, you must:
• adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient
• promptly provide or arrange suitable advice, investigations or treatment where necessary
• refer a patient to another practitioner when this serves the patient’s needs.
In providing clinical care you must:
• provide effective treatments based on the best available evidence
• consult colleagues where appropriate.’
24. The records indicate the emergency team assessed Mrs P and found her to be conscious and breathing with the support of supplemental oxygen therapy. The emergency team noted her oxygen saturation levels were still low (93%) despite the oxygen therapy, her heart rate was high (108 beats per minute) and her BP was elevated (115 systolic). The emergency team provided intravenous (IV) fluid treatment and transferred Mrs P to the resuscitation section of the ED for further assessment and treatment.
25. The records indicate the Trust diagnosed Mrs P with anaphylactoid reaction (an immediate systemic reaction) to CosmoFer and continued her treatment with IV fluids and supplementary oxygen. The Trust also provided medication to help relieve her symptoms of pain and nausea and inserted a catheter to help maintain her fluid balance. The Trust sent blood samples for testing and performed a CT scan to rule out pulmonary embolism as the cause of her low oxygen saturation level.
26. Mrs P’s condition gradually improved in the ED. The records indicate her NEWS improved from 5 (a rating of 5 or more is the key trigger threshold for urgent clinical review and action) at the point of her admission to the ED, to 4 (a rating of 0-4 indicates low risk of imminent clinical deterioration) at 11:31am, then 3 at 1:44pm and 2 at 5:46pm. The Trust then transferred Mrs P to the HDU for further observation and treatment.
27. Our ED adviser said the records indicate the action taken by the emergency team following the call from the nursing team was appropriate and carried out in line with the RCUK guidance. Our ED adviser said there is no evidence in the records to indicate there was any further action the emergency team could have taken or any further care or treatment it could have provided to Mrs P at this time.
28. We carefully considered Mr F’s complaint and the supporting information he has provided. We also considered the information in the records, the guidance and the advice we have received. We found no evidence to indicate the Trust failed to provide the appropriate care and treatment to Mrs P after she became unwell during the infusion.
29. The Trust acted in line with the NMC code, the RCUK guidance and the GMC guidance in attending to Mrs P promptly, assessing her and transferring her immediately to the ED for further treatment. The records indicate Mrs P’s condition improved in the ED enabling her to be transferred to the HDU for further assessment and treatment.
The Trust failed to provide appropriate care and treatment to prevent her condition deteriorating after she was admitted to the HDU
30. Sepsis is a serious condition that happens when the body’s immune system has an extreme response to an infection, often originating from bacterial infections. The NICE sepsis guidance says when an infection is suspected clinicians should:
‘Give people aged 16 or over who are at high risk of severe illness or death from sepsis broad-spectrum intravenous antibiotic treatment, within 1 hour of calculating the person's NEWS2 score on initial assessment in the emergency department or on ward deterioration.
When the source of infection is confirmed or microbiological results are available, review the choice of antibiotics and change the antibiotics according to results, using a narrower-spectrum antibiotic, if appropriate.’
31. The NICE coronary guidance says:
‘Initial drug therapy
Offer aspirin as soon as possible to all people with unstable angina or non‑ST‑segment elevation myocardial infarction (NSTEMI) and continue indefinitely unless contraindicated by bleeding risk or aspirin hypersensitivity.
Offer people with unstable angina or NSTEMI a single loading dose of 300-mg aspirin as soon as possible unless there is clear evidence that they are allergic to it.’
32. The records indicate following her recovery in the ED, Mrs P was admitted to the HDU at 6.30pm for further tests, observations and treatment. On 5 August 2022 the Trust performed further blood tests which showed increased white blood cells and raised levels of C-Reactive protein (CRP, a marker of inflammation and/or infection).
33. Our physician adviser said these findings indicated a bacterial infection and the Trust started treatment with wide-spectrum antibiotics (antibiotics that act against a wide range of disease-causing bacteria) in line with the NICE sepsis guidance. The Trust sent additional blood and urine samples for testing to confirm the source of the infection and consulted with the microbiology department to establish the appropriate choice of antibiotics to use going forward.
34. Mrs P’s blood tests also showed a very high troponin level. Troponin is a protein found in heart muscle cells which is released into the bloodstream when these cells are damaged. A troponin blood test is used to detect heart damage, especially in cases of suspected heart attack.
35. The records indicate the Trust performed an electrocardiogram (ECG, a test that measures the electrical activity of the heart) which identified changes consistent with ischaemia (restricted blood flow to the heart). Our physician adviser said these findings indicate a heart attack and the Trust provided treatment with blood thinning medication and aspirin. Our physician adviser said despite the findings in the test results the records indicate Mrs P remained medically stable at this time.
36. The records indicate at 5.30pm on 6 August 2022 Mrs P suffered a sudden deterioration with a change in her breathing pattern, low oxygen saturation level and she became unresponsive. The resuscitation team arrived at 5:40pm and after assessing her condition the Trust decided there was no further curative treatment options it could provide to Mrs P. The records indicate at this point the Trust believed Mrs P was nearing the end of her life and decided to focus her care on ensuring she remained comfortable. Mrs P sadly died next day.
37. Our physician adviser said the records indicate Mrs P was reviewed by senior doctors (consultant and registrars) during her time on the HDU and the Trust monitored her condition using the NEWS standards. The records indicate the Trust performed appropriate tests which identified signs of bacterial infection and heart attack. The records indicate the Trust provided treatment with antibiotic medication for the infection in line with the NICE sepsis guidance and treatment with aspirin and blood thinning medication for the effects of the heart attack in line with the NICE coronary guidance.
38. We carefully considered Mr F’s complaint and the supporting information he has provided. We also considered the information in the records, the guidance and the advice we have received. We found no evidence to indicate the Trust failed to provide the appropriate care and treatment to Mrs P following her transfer to the HDU. The Trust acted in line with the NICE sepsis and coronary guidance.
39. We found no evidence to indicate there was any additional treatment that could have been provided by the Trust or that Mrs P’s death could have been prevented.