The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a Field Safety Notice to alert healthcare providers and customers regarding the HeartWare® Controller (Product code: 1400) manufactured by HeartWare, Inc.
An investigation of a single customer report has confirmed that it is possible in a specific circumstance for medium priority (Low Flow, High Power, and Suction) alarm limits to be exceeded without an audible notification or a visible alarm message being displayed on the HeartWare Controller. The reported condition will only occur if the Controller has Lavare Cycle turned on and then, when connected to a Monitor, the Lavare Cycle is turned off during the initial eight seconds of the cycle. There are no reported adverse events or complications associated with the report, and the alarm suppression is not associated with resetting (short-restart) of the HVAD Pump.
A clinical risk to a patient would most likely occur if there were a VAD thrombus or occlusion event that caused high watts or low flow. The clinical risk could include failure to provide a warning to the patient that a low flow state existed. Such a state would cause symptoms such as hematuria or heart failure to occur and lead the patient to seek medical attention. While death under such circumstance is not likely, low flow ischemia to various organs (e.g. kidneys) could result in reversible impairment that could be corrected by restoring full flow.
According to the manufacturer, the affected products have NOT been distributed in Hong Kong. For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected products, please contact your supplier for further information and necessary actions.