FDA issues letter to health care providers for HVAD internal pump malfunction
The FDA issued an alert to health care providers of a welding defect in the internal pump of Medtronic’s ventricular assist device that may cause pump thrombosis and pump malfunction.
According to an FDA press release, Medtronic issued an urgent medical device correction to inform health care providers of the defect in these devices (Heartware Ventricular Assist Device).
The company is conducting an investigation to identify which pumps may be affected, according to the release.
The company reported receiving three complaints of patients with suspicion of pump thrombosis where inspection identified a malfunction of the internal pump. According to the release, pump exchanges were performed in all three; however, two patients died after the exchange.
The three patients presented with at least one of the following signs:
- grinding sound;
- transient power spikes on the log files and high watt alarms;
- elevated lactate dehydrogenase;
- low motor speed resulting in low perfusion; and
- dizziness or lightheadedness.