Following four deaths and five injuries to patients, California-based medical devices company Thoratec Corporation revealed that it will be sending safety advisory to hospitals for the use of its pocket system controller for mini heart pump device, HeartMate II.
A new system controller for HeartMate II, which is a left ventricular assist device (LVAD), was launched by the company back in Europe in 2012 and introduced it to the American market in 2013. The device is implanted in people suffering from advanced heart failure and helps the heart to pump blood.
It is connected to external battery pack and a system controller sends an alert when the battery runs low and the user can shift primary system controllers to backup system controllers before changing it.
The company revealed that four people died and five others suffered lost consciousness or suffered decreased blood flow when attempting to change the controller themselves and added that the lives were lost not because of any defects in the device but due to lack of proper training.
Dr Liviu Klein, a cardiologist at the UCSF Heart and Vascular Center, admitted that the blame lies with the physicians and the caregivers rather than the company. "It's a new controller. The blame I don't think falls on the company. It falls on the physicians and the caregivers that did not spend enough time on the patients, did not spend enough time making sure they get the appropriate training", Dr Klein said.