Recent updates have been made to HeartWare’s Ventricular Assist System Class I recall. A Class I recall is the U.S. Food and Drug Administration’s (FDA’s) most serious types of recall; it means that exposure to the device can reasonably lead to serious injury or death. Previously, HeartWare described five different types of complaints associated with the product and issued a voluntary Urgent Medical Device Correction of May 11, 2015. The press release listed the following types of complaints: maintaining continuous power supply, worn alignment guides, power management software upgrades, driveline outer sheath discoloration and cracking and driveline pulling and snagging. The recall affects product codes 1101 and 1103.
The device circulates blood from the heart to the rest of the body. The HVAD is for patients who are at risk of dying due to end-stage left ventricular heart failure and those waiting for a heart transplant. A pump is implanted in the pericardium, or space surrounding the heart. The system’s speed and function can be altered with a controller.
The recall was updated to include more information about troublesome issues. On June 16, “damaged alignment guides/connection pins may cause pump to stop” was added. “The alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their HVAD.” the recall alert states. If this problem causes the pump to stop, it can result in patient injury or death. This problem was cited in 33 reports of malfunction and linked to one serious injury.
On June 19, “battery failure may prevent alarm from sounding” was added. The controller contains an alarm that goes off if both external power sources for the HVAD are disconnected. The notification states that the battery powering this alarm may stop working over time, failing to alert patients of this issue. “The HVAD should never be disconnected from both power sources at the same time because the pump will stop working. If a pump stop occurs, the potential risk for the patient ranges from minimal temporary symptoms of hypoperfusion to cardiopulmonary arrest and death.” the alert states. This issue has been linked to three injuries and one death.
The recall was also modified on June 19 to indicate that “damage to driveline connector may cause electrical issues or pump stops”. This issue has been linked to two deaths and one serious injury. According to the recall notice, “Damage to the driveline connector may occur if the driveline is pulled too often with too much force. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Severe damage or disconnection of the driveline from the controller can cause electrical issues or pump stops that may lead to serious patient injury or death.”
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from Parker Waichman http://www.yourlawyer.com/blog/heartware-ventricular-assist-system-recall-updated-with-multiple-issues/
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