The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning HeartWare HVAD Pump Implant Kit. Below please see the details of the affected devices:
According to HeartWare, an investigation of customer complaints has confirmed a small number of events (11 of approximately 2900 implants) where the rear portion of the HVAD Pump's driveline connector housing becomes partially separated or fully separated from the front portion of the driveline connector. In the unlikely event of a separation, a repair may be necessary. If left unattended, electrical connection to the controller could be affected and a stop alarm could result. HeartWare reported that none of the 11 confirmed events resulted in harm to the patients affected.
HeartWare is implementing manufacturing process changes to prevent recurrence of this event. Meanwhile, users are advised to inspect the patient's driveline connector at each routine clinic visit.
For details, please refer to MHRA website:http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON234577
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 February 2013