Abbott is warning of two separate potential safety issues involving its HeartMate 3 implant used to treat advanced heart failure, according to MedTech Dive.
The HeartMate 3 is designed as a long-term treatment for patients with advanced heart failure who can't receive a heart transplant.
Medical professionals need to perform controller exchanges on the pumps every once in a while, but patients and caregivers are also trained to perform exchanges in case of an emergency.
Abbott warned that connecting the modular cable to the HeartMate 3 at the wrong angle when exchanging controllers can stop electrical power from reaching the pump, which can cause serious injury or death. The cable may seem like it is connected, but if it's at the wrong angle, it won't transmit electricity to the pump, according to MedTech Dive.
Abbott wrote in a Dec. 2 letter to clinicians that the problem has resulted in a reported death rate of 0.05 percent to date. It has also caused hemodynamic compromise — which is when blood flow from the device is reduced or stopped — in 0.07 percent of patients. The company did not specify the number of deaths caused by the problem.
The second issue is that excessive amounts of static electricity have caused unrecoverable power loss to the HeartMate mobile power unit modules. There have been two reports of serious injury connected to the issue, but no deaths. The serious injuries were hemodynamic compromise.
The static electricity problem only occurs when the HeartMate 3 system is used with the MPU Module, according to MedTech Dive. HeartMate II devices are not affected.
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