Medical device manufacturer, HeartWare (now a part of Medtronic), has issued a medical device safety alert concerning its HVAD Systems. The affected devices are identified as the following: -
The manufacturer informs healthcare professionals of the potential for a transient interruption of the electrical connection between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the HVAD Controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones ("beeping"). This interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller's power source socket, and typically lasts 1-2 seconds. Unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or ACIDC connectivity at the time of the audible tone. A Critical Battery Alarm may also be momentarily displayed due to this phenomenon.
According to the manufacturer, the projected occurrence rate of unexpected power source switching with the HVAD System over a 2-year period on a per patient basis is approximately 25%. Approximately 97% of reported occurrences of this issue resulted in no patient symptoms. However, the potential harm associated with transient power source interruptions can vary, depending on whether two power sources are connected (as instructed in the Instructions for Use and Patient Manual) versus a single source, and the patient's underlying health. The per patient probability of serious adverse events due to this issue is approximately 0.003.
The manufacturer has continued to develop and implement enhancements into the HVAD System to improve power source connectivity and reduce the potential for unintended power source switching. Affected users should follow the manufacturer's recommendations for effective power source management of the HVAD systems.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 May 2018