In a June 7 letter, Abbott said it received “limited” reports of communication errors between the HeartMate 3’s system controller and the pump itself, the next-generation left ventricular assist device that came to the company after its acquisition of St. Jude Medical.
“We have identified the potential for a communication error between the patient’s system controller and the [left ventricular assist system] pump which triggers a communication fault advisory alarm on the system controller. We have traced the issue to manufacturing variances from a single supplier that could lead to crystallization formation, which may then disrupt communication between the pump and the system controller. Abbott has updated the specifications and manufacturing processes to ensure this issue does not occur in future lots of manufactured HeartMate 3 devices,” the company wrote in the letter. “To date, there have been no patient effects related to this situation; however, there are frequent advisory alarms that need to be silenced.”
Abbott stressed that the HeartMate 3 system has a redundant communication line. There were 11 reports of communication line faults out of 850 implanted devices (a rate of 1.3%), including eight cases in which only one of the communication lines went down. “In these instances communication between the System Controller and pump was still available,” the company said.
There were two reports of intermittent failures of both lines and one report “in which both communication lines appear to be permanently affected,” Abbott said, noting that it retrieved the affected inventory from its hospital customers and replaced it with unaffected HeartMate 3 devices.