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Thoratec Issues Device Correction after 2 HeartMate II Patients Die

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Thoratec has issued a voluntary Urgent Medical Device Correction Letter after two patients using HeartMate II left ventricular assist system (LVAS) died and one became seriously injured. According to FierceMedicalDevices.com, the deaths occurred when patients were not able to connect their devices to a backup system controller in time.

The deaths and serious injury arose from confusion over how to properly use the device, FierceMedicalDevices.com reports. The problem stems from a “yellow wrench” alarm that goes off to remind users to check up on the expiration date of the backup battery; it does not mean that system is malfunctioning. The adverse events occurred when patients mistakenly tried to swtich to the backup system after the alarm went off. Thoratec said in a release, “The Urgent Medical Device Correction Letter is intended to prevent the occurrence of certain preventable advisory alarms that may result in patients deciding to attempt a System Controller exchange. Thoratec is working with hospital staff to identify patients that may be close to reaching the 36-month expiration date of their System Controller backup battery in order to facilitate priority replacement and to ensure routine monitoring of backup battery lifetime during clinic visits, as specified in the product Instructions for Use,”

The recall has not yet been classified by the U.S. Food and Drug Administration (FDA). According to FierceMedicalDevices.com, it is likely that the agency will give its most serious Class 1 classification, which is reserved for devices that present a reasonable risk of serious injury or death.

Last year, the FDA issued a Class 1 recall after four HeartMate II patients died while trying to switch to a backup system when their external battery ran low on power.

breakinglawsuitnews.com disclaimer: This article: Thoratec Issues Device Correction after 2 HeartMate II Patients Die was posted on Thursday, September 17th, 2015 at 1:56 am at breakinglawsuitnews.com and is filed under Uncategorized.

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