Thoratec HeartMate II 血液幫浦系統接線 更換

(http://bme.freebbs.tw 醫學工程論壇同步發表)

國內有進 衛署醫器輸字第018246號 ,

登記名稱 HEARTMATE XVE Left Ventricular Assist System

跟FDA發佈的HeartMate II Left Ventricular Assist System (HM II LVAS)不是很相同

建議 醫院有這款設備,應該跟代理商詢問一下

Audience: Cardiologists, cardiovascular surgeons, hospital risk managers
[Posted 10/28/2008] Thoratec Corporation notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having Catalogue No. 1355 or 102139),

distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death.

The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead.

原資料網址

http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeartMate