Important Safety Alerts

Medical device manufacturer, Medtronic, has issued medical device safety alert concerning two separate issues.

The first issue is on the following products:

• HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller Ports:
  • Controller AC Adapter [Product Number: 1425, 1430]
  • Controller DC Adapter [Product Number: 1440]
  • Battery [Product Number: 1650, 1650DE, 1650CA-CLIN]
  • Alarm Adapter [Product Number: 1450]
  • Monitor Data Cable [Product Number: 1575]
  • Controller [Product Number: 1400, 1401, 1403, 1407XX, 1407CA_CLIN]

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to misalignment of the cables to the port.

According the manufacturer, repeated misalignment causes wear on the power cables and data cables and may cause damage or bending on the Controller port metal pins. This damage can result in the inability to fully lock the cable connectors into the Controller, potentially causing interruptions or disconnections in power to the Controller, which may result in controller power loss and HVAD Pump stop or loss of communication to the HVAD Monitor. When this occurs, it may be necessary to exchange the Controller to restore connections between the power sources and Controller.

The second issue is on the Instructions for Use (IFU) and Patient Manual (PM) updates to the HeartWare HVAD System.

According to the manufacturer, the IFU updates will (i) provide new information relating to the useful life of the HVAD System carrying cases (Waist Pack, Shoulder Pack, and Convertible Patient Pack), (ii) clarify the HVAD Controller connections, power-up sequence, and notifications, and (iii) clarify expected duration of HVAD System alarms. The PM update will (i) provide additional information relating to the care and use instructions for the HVAD System carrying cases and (ii) provide additional information relating to the HVAD Controller driveline cover.

To address the above-mentioned issues, the manufacturer is advising affected users to refer to relevant urgent medical device notice in order to mitigate damage to the connector pins. Affected users are also advised to review the updated IFU and PM.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 3 March 2021