Medical device manufacturer, HeartWare Incorporation, has issued a medical device safety alert concerning its HVAD Pumps. The affected devices are identified as follows:-
The manufacturer has reviewed certain complaints related to the HVAD System and announced a voluntary recall of specified implant kits (pumps) in hospital inventory, which may be more susceptible to electrical faults if the driveline becomes contaminated.
According to the manufacturer, contamination of the driveline-to-controller connector can occur during the implant procedure or post operatively from fluid ingress into the driveline. Connector contamination of the driveline has been seen to occur most often in the first 30 days post implant. Affected devices that have already been implanted into a patient are not subject for removal.
The presence of fluid or foreign material at the driveline/controller connector may impact the function of the pump and controller. Specifically, foreign material at the driveline/controller connector could lead to electrical faults and connection failures. In these scenarios, potential risks include interruption of circulatory support due to a pump stop, which could cause serious injury or death.
The manufacturer has implemented manufacturing process improvements designed to prevent driveline connector contamination in new implant kits. Users are advised not to attempt to repair or service any components of the HeartWare System. If the HeartWare System equipment malfunctions, they should promptly contact their local representative.
According to the local supplier, the affected serial numbers are NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 August 2016