The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning HeartWare Ventricular Assist System batteries manufactured by HeartWare Inc. The affected product code is 1650. All HeartWare battery serial numbers are affected.
The manufacturer has seen an increase in complaints related to both premature battery failure and routine battery handling. Premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death.
Early recognition of premature battery depletion, patient training and close attention to recommended power management practices are crucial to reduce patient risk. Therefore, the manufacturer is providing patients and health professionals with information to recognise batteries with less than two hours of run time, re-emphasise instruction on actions to take when battery alarms occur and reinforce proper power management.
The manufacturer is closely monitoring the complaints to ensure that the HeartWare System functions as intended and to assess the effectiveness of the field correction.
The manufacturer will continue to investigate prematurely depleting batteries and will take additional actions as appropriate.
For details, please refer to TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00510-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 08 May 2014