26 die after attempting to replace Abbott’s blood pump controller themselves
pharmafile | May 24, 2017 | News story | Medical Communications, Sales and Marketing | Abbott, FDA, Medical device, deaths
At least 26 advanced heart failure patients have died and 19 have been injured by attempting to change the controller on Abbott Laboratories’ HeartMate II blood pumps themselves at home. The manufacturer released new software and alarm guides concerning almost 29,000 devices to doctors on 30 March, after 70 reports of malfunctions following an unsuccessful controller replacement.
The HeartMate II Left Ventricular Assist Device (AVLAD) blood pump is an implantable medical device which Abbott acquired its original owner St Jude Medical in January this year. When installed in a patient, it works to pump blood round the body when the heart is too weak to function unaided. The device features an external Pocket System Controller in order to operate it, but this must be replaced – Abbott has advised that replacements only be conducted by clinical professionals due to the difficulty it can present to users.
Because of the dangers posed to users, the FDA has this week issued a Class 1 recall – the most severe of its kind – urging users to refrain from changing controllers themselves.
“Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy,” the recall notice noted. “The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper…changeover places them at risk of serious injury or death.”
Boasting a six-figure price tag, the device was designed to keep patients alive until they could undergo a heart transplant, but the FDA gave its approval for it to be used as a destination therapy in those who do not qualify for such a transplant.
Abbott responded to the FDA’s decision by noting that it is currently engaged in continuing practices to ensure the safety of the device. Abbott spokesperson Justin Paquette commented: “We are updating its alert guides, conducting a software upgrade and adding controller alignment markings for the HeartMate II System Controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations. Despite past efforts to improve training and education, we are aware of patients experiencing a very low level of adverse events as a result of unnecessary patient controller exchanges.”
“This has been classified by the FDA as a Class I recall, however this is not about recalling products,” he continued, “rather, the focus is on communication to physicians so they can ensure their patients have their controller exchange completed in a clinical setting. We have also updated our software and controller alerts to help guide patients to talk to their physician when the time is approaching to have their controller exchanged.”
Matt Fellows
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