MHRA Issues Warning On Drager Latex Breathing Bags

Alert On Allergic Reaction Risks Linked To Specific Product Numbers

15.07.2014

A medical device alert has been issued by the Medical and Healthcare products Regulatory Agency (MHRA) related to specific product lines of reusable latex breathing bags manufactured Drager.

Concerns have been raised after it was found there is potential for an acute allergic reaction in staff or patients after using those carrying the affected product numbers.

The following numbers are affected:

  • Reusable latex breathing bags: 2165686, 2165953, 2165694, 2165708, 2165716, 2165724, 2165763, 2165775 and 2165783.
  • Reusable latex breathing bags used with test lung: 8403201.
  • Reusable latex breathing bags used with reusable anaesthesia sets: M33681, M27542, M34822, M34823 and M34824.

Medical professionals have been urged to be aware of the issues and also note that the breathing bags are marked with NR for natural rubber, although this may not be immediately obvious.

Expert Opinion
There is rightly an expectation among patients and the families of those being treated in hospital that a high standard of care will always be provided and that allergic reactions will be asked about and factored into patient care.

"In order to ensure this is the case, it is vital that the tools which medical professionals are given are suitable and safe for use. As a result, reports of this nature are clearly a concern and it is vital they are fully investigated.

"Through our work on cases related to defective medical devices, we have seen numerous examples when people have suffered illness and injury as a result of product usage which simply should have been avoided.

"Patient safety in circumstances like this is about making small gains in the standard of care which significantly improve the experience of care by the patient."
Kevin Timms, Solicitor