The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) issued a medical device alert concerning Perfusor Space infusion pump (reference code 8713030) and battery pack (reference code 8713180) manufactured by B. Braun Medical Ltd.
According to the manufacturer, when an aged battery (4 years or older) is used, the pump may not have sufficient power to perform a syringe change, despite the battery indicator on the pump showing a full charge. The therapy could stop unexpectedly. This is because a syringe change requires a large current which may not be available if the battery has been significantly aged.
- Braun explains that the problem does not arise if the pump is plugged into the mains and it does not affect running infusions. Although there have been no reports of adverse incidents related to this matter, B. Braun advises the affected clinical users and technical staff to:
- be aware that this issue presents a risk when the pump is used on battery only (for example during patient transfer) and is particularly relevant to patients on life sustaining or other critical medications.
- always have an additional pump available, for infusions of critical medications.
- remove the pump from use if this problem occurs and return the affected pumps with aged batteries for replacement.
- refer to the updated service documents for further details including how to identify the age of the battery and relevant test procedures.
- test or replace the affected batteries as soon as possible if the above mentioned problem occurs.
- test or replace the batteries during the next maintenance if the battery problem has not been reported so far.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON341212
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 November 2013