HEALTH chiefs in England have ordered an urgent investigation after one baby died and 14 fell ill from blood poisoning.
Public Health England (PHE) said 15 babies in six hospitals across the country contracted an infection believed to be from contaminated drips.
The babies developed septicaemia after being infected with the bacteria known as Bacillus cereus, a spokesman said.
PHE said that the cases have been “strongly linked” with a number of batches of a particular form of intravenous liquid called total parenteral nutrition, which was given to the babies.
The liquid, manufactured by London-based ITH Pharma Limited, is supposed to deliver a variety of nutrients intravenously when a baby is unable to feed on its own, and the infection is believed to have come from suspected contaminated drips.
A recall has been issued by the manufacturer and the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a “Class 1” drug alert to draw attention to the product.
Class 1 is the most critical alert and requires immediate recall.
PHE and the MHRA have confirmed they are investigating 15 cases of blood poisoning.
The affected babies were in neonatal intensive care units at a number of hospitals in England. The hospitals were: Chelsea and Westminster (four cases); Guy’s and St Thomas’ (three cases); Whittington (one case), all in London; Brighton and Sussex (three cases), Addenbrookes in Cambridge (two cases); and Luton and Dunstable (two cases) in Bedfordshire.
The hospital at which the baby died has not been named.
PHE said that doctors have also been given advice on identifying any potential cases of infection and how to dispose of affected stock.
Professor Mike Catchpole, of PHE, said: “This is a very unfortunate incident and PHE has been working closely with the MHRA to investigate how these babies could have become infected. 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.”
A PHE statement said: “Many of the babies were premature and very vulnerable and one baby has sadly died but the others are responding to antibiotic treatment.
“Investigations are ongoing but so far indications show that the cases have been strongly linked with a number of batches of a particular form of intravenous liquid called parenteral nutrition which was given to the babies.”
Bacillus cereus is a bacterium found widely in the environment in dust, soil and vegetation. Most surfaces would be likely to test positive for the presence of the bacteria.
ITH Pharma Limited was not available for comment.