A baby dies from blood poisoning after being put on a drip containing a contaminated substance and 14 other babies are being treated with antibiotics after falling ill at NHS hospitals.
The baby who died was being treated at Guy’s and St Thomas’ NHS Foundation Trust in London.
Public Health England (PHE) said the cases have been “strongly linked” to a number of batches of intravenous liquid called parenteral nutrition, which was given to the babies.
The liquid, manufactured by ITH Pharma Limited, is supposed to deliver a variety of nutrients intravenously when babies are unable to eat on their own.
A PHE statement said investigations with the company have identified “an incident that might have caused the contamination”.
The affected babies were in neonatal intensive care units at three London-based NHS organisations – Chelsea and Westminster NHS Trust, Guy’s and St Thomas’ NHS Foundation Trust and the Whittington Hospital – as well as Brighton and Sussex University Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust and Luton and Dunstable University Hospital.
A spokeswoman for Guy’s and St Thomas’ said: “The infection has affected three babies. Sadly one of these babies has died. The other two are responding well to antibiotics.
“All babies on the unit are being screened for the bacterium as a precaution and enhanced infection control measures have been put in place to prevent any further cases. These enhanced measures will remain in place until the Trust is satisfied that no other babies are at risk.”
PHE said: “Many of the babies were premature and very vulnerable and one baby has sadly died, but the others are responding to antibiotic treatment.”
PHE and the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that an investigation has been launched into the issue.
The manufacturer has issued a recall and the MHRA has issued an alert to draw attention to the product recall.
PHE said that doctors have also been given advice on identifying any potential cases of infection and how to dispose of affected stock.
The product has a short shelf life and although it is unlikely that any stock from the day of contamination incident remains (it expired on 2 June), the MHRA has issued a class 1 drug alert.
“This is a very unfortunate incident and PHE have been working closely with the MHRA to investigate how these babies could have become infected,” PHE’s incident director, Professor Mike Catchpole, said.
The MHRA and Public Health England only issue class 1 drug alerts when action is required immediately to remove the product from the shelves, writes Health and Social Care Correspondent Victoria Macdonald.
In this case, it is not believed that any stocks are remaining because it does have such a short shelf-life but they need all hospitals to check.
Bacillus cereus is an environmental pathogen, quite often the cause of food poisoning, for instance when rice has been left out. It can also breed on cereal products and pastas, though this is less common. In healthy children and adults it is generally nothing more than unpleasant but these were vulnerable, premature babies.
An MHRA spokesman said that it is thought that the product became contaminated during the production process but investigations at the north west London plant are continuing.
“Given that the bacteria is widely spread in the environment, we are continuing to investigate any other potential sources of infection. However all our investigations to date indicate that the likely source of the infection has been identified.
“We have acted quickly to investigate this issue alongside the MHRA and we have taken action to ensure that the affected batches and any remaining stock of this medicine is not being used in hospitals.”
Adam Burgess, manager of the MHRA’s defective medicines reporting centre, said: “Patient safety is our top priority and we are working alongside PHE to establish what has happened.
“We have sent inspectors to the manufacturer’s facility to carry out a detailed and rigorous inspection and we have ensured that the potentially affected medicine is recalled.”
TH Pharma Limited was not available for comment.