- Medicines and Healthcare products Regulatory Agency and Public Health England
- 6 June 2014
PHE and MHRA continue investigation into cases of septicaemia caused by Bacillus cereus.
Public Health England (PHE) can report that 3 further cases of blood poisoning (septicaemia) in babies being treated in neonatal intensive care units in England, have been identified after looking back at clinical records. These babies received the potentially affected batches of intravenous liquid before Tuesday 3 June, when the affected stock expired. This takes the total number of cases to 21, with 1 death.
The babies, who became unwell last week or over the weekend, are responding to antibiotic treatment.
Dr Brian McCloskey, PHE Incident Director, said:
PHE has been working closely with the neonatal units who received the potentially contaminated batches of Total Parental Nutrition (TPN). All babies who received the potentially contaminated feed have been closely monitored and we have been actively looking at previous case records for any signs of the infection. Because of this, earlier cases are now being included in our total numbers.
Although there is a possibility that babies who developed an infection last week or over last weekend will continue to be reported as a result of our investigations, due to the time that has passed since the product expired, we can be reasonably sure that this number will be very small, but we are keeping a close eye on the situation.
The Medicines and Healthcare products Regulatory Agency (MHRA) is continuing its investigation into this incident and the manufacturer is co-operating fully.
Gerald Heddell, the MHRA’s Director of Inspection, Enforcement and Standards, said:
We have inspected the ITH Pharma facility as part of our investigation into the potentially affected batches of intravenous liquid.
Based on the information we currently have, we believe this is an isolated incident and the appropriate immediate action has been taken at ITH Pharma’s facility to avoid a reoccurrence. Therefore we are allowing this critical product to be supplied to patients while our investigation proceeds.
At this stage, we believe the facility is operating in accordance with Good Manufacturing Practice guidelines but further inspections will be made as part of our ongoing investigation.
Unless there are any significant developments, this will be the last update on this investigation until next week.
Notes to Editors
- One probable case at the Stoke Mandeville Hospital, Buckinghamshire – baby with clinical symptoms, awaiting confirmation on further testing
- One possible case at Chelsea and Westminster NHS Trust – baby with clinical symptoms, blood testing did not confirm the infection
- One possible case at CUH Addenbrookes – baby with clinical symptoms, blood testing did not confirm the infection
- Neonatal intensive care units with cases:
- Chelsea and Westminster NHS Trust (4 confirmed, 1 possible)
- Guy’s and St Thomas’ NHS Foundation Trust (3 confirmed)
- The Whittington Hospital (1 confirmed)
- Brighton and Sussex University Hospitals NHS Trust (3 confirmed)
- CUH Addenbrookes (Cambridge University Hospitals) (2 confirmed, 1 possible)
- Luton and Dunstable University Hospital (2 confirmed)
- Peterborough City Hospital (1 confirmed)
- Southend University Hospital (1 probable)
- Stoke Mandeville Hospital (1 probable)
- Basildon University Hospital (1 possible)
Infections press office
PHE press office, infections
61 Colindale Avenue
Phone 020 3682 0574
Out of hours 020 8200 4400
The MHRA press office can be contacted on 020 3080 7651, at email@example.com or on our out-of-hours number 07770 446 189
Published: 6 June 2014