Another Medical Device Alert for Intra-Aortic Balloon Pump for a different fault!

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued another medical device alert for intra-aortic balloon pumps, made by Maquet/Getinge. The alert closely follows the one issued over the Datascope Corp’s similar devices that were found to have an electrical fault.

This new alert identifies a “false blood detection alarm and/or fluid ingress” that can also risk failure of therapy to patients. The medical device is used to help the patient’s blood flow, pumping at the same rate as a heartbeat, and is usually used for patients whose hearts may not be strong enough to function alone.

It’s therefore a vital device indeed.

If there is not enough oxygen-rich blood being carried around the body, patients could experience serious health implications, including organ failure.

Datascope/Maquet issued a Field Safety Notice on 17^th July 2017, noting the serious issues and the urgent corrective measures to fix the devices.

The Manufacturers have identified that condensation in some of the tubing may trigger the blood detection alarm in the device. This ‘false’ blood detection can lead to physicians misunderstanding what’s going on, and the alarm can only be turned off by manually turning the pump off at the power and then turning it back on. If a false blood detection alarm goes off, it could cause unnecessary and serious delays to the use of the device. If this fault is identified, the device may need a hardware change.

The devices, as electro-mechanical systems with electronic circuit boards, could be vulnerable to short-circuiting and other electronic problems in the event liquid comes in to contact with certain components. This could impact the initiation and continuation of therapy. The pumps carry a warning to “never place fluids on top of the unit. Make sure that the saline container and tubing to not hang directly over the IABP.”

Maquet/Getinge have identified the potential fluid entry points and have made a gasket kit to seal them.

Whilst these problems may not seem all that serious – a glitch here and some delay there – a slight interruption can mean life or death for the most vulnerable and critically-ill patients. Even for those with less-than-critical conditions, an inactive balloon inside their hearts for more than half an hour could result in the formation of dangerous blood clots.

Failure of the heart balloon pumps can have very serious, immediate and adverse health consequences, including death itself. This has been recognised by the U.S., who issued the most serious Class I recall over affected devices. CS100i, CS100 and CS300 intra-aortic balloon pump are reportedly affected by the alert.

All clinicians and doctors who use the devices are urged to use alternative IABP or therapy treatment if possible. Staff are requested to contact Maquet to schedule an appointment for a service representative to carry out the updates for the blood detection circuit as well as waterproofing the device.

Those who have no alternative may need to  make a risk assessment based on a risk vs the benefit of using the device. Surgeons also need to inform patients or their representatives of the risks involved.