Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its HeartWare Ventricular Assist Device (HVAD) System[ [Model number: [<1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU>]
The manufacturer internal testing has shown that it may be difficult to pull back the driveline cover over a strain relief repair when attempting to access the driveline connector. According to the manufacturer, difficulty in pulling back the driveline cover over a strain relief repair may cause a delay in accessing the driveline connector. This delay may lead to a prolonged pump stop if access to the driveline connector is required to address a marginal driveline connection or change controllers. In addition, pulling back the driveline cover over a driveline strain relief repair may also compromise the integrity of the repair.
According to the manufacturer, they received three complaints (two in 2012 and one in 2016) related to the inability or difficulty in pulling back the driveline cover over the repair, all of which reported no or negligible patient harm. In addition, the manufacturer received one complaint in 2013 where a patient taped over the strain relief, without manufacturer involvement. This self-repair later interfered with reconnecting the driveline, resulting in hospitalisation and patient death due to related complications.
The following actions are recommended by the manufacturer to affected users:
According to the local supplier, the affected products are NOT distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 16 Aug 2021