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

Nebion HLX-8 一級回收

(http://bme.freebbs.tw 醫學工程論壇同步發表)

 

國內好像沒進，衛生署上也沒登記，有的話就是自己帶進的水貨，要多注意。

Nebion HLX-8 一級回收

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

Nebion HLX-8 Magnetic Resonance Device
Audience: Healthcare professionals, consumers
[Posted 10/03/2008] FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

[October 03, 2008 - Recall Notice - FDA]  

超低溫冷凍櫃 Thermo 705 颱風天淋到水

(http://bme.freebbs.tw 醫學工程論壇同步發表)

 

名稱:超低溫冷凍櫃 Thermo 705

故障情形：颱風天淋到水

故障原因： 颱風天

 

這次的薔蜜颱風真的是強，醫院17樓的加蓋鐵皮屋屋頂，被掀了一塊！雨水灌了進來，當下冒著風雨趕到了醫院，幫忙值班的同事，搬遷設備。

 

水越來越多，小設備都還好，搬了就走，直到剩下這台超低溫冷凍櫃，很重耶，沒5,6個是抬不動的，再加上風雨還很大，為了安全，只好把他留在災區，加了一些防水的措施，請工務課把災區封起來，作為損壞隔離，只希望颱風"回南"時別太大，看能不能過關。

 

颱風過後，開始復原，只剩下這台超低溫冷凍櫃，確定內部都乾燥後，溫度由原來的 -81 回升到 -33，趕緊插電試機囉，結果等了快3個小時溫度還是 -33,判斷應該是結冰了,所以溫度下上不下，請單位的人把裡面的檢體全部拿出來，準備讓超低溫冷凍櫃作除霜的動作。

 

放了一個晚上，大概冰都退了，再插電試機，咦，好像壓縮機都沒動作，想說是不是保護裝置，再等一下吧，等了約30分，還是沒動靜，糟了，會不會壓縮機掛了，那可就慘了，打電話去代理商問，原來是啟動程序有問題，開機順序

 

1.關開前面電池開關

2.插電源線

3.開背後電源開關

4.開前面電池開關

 

這樣電路才會重置，壓縮機終於運轉了，聽到壓縮機運轉的聲音，總算是鬆了一口氣，隔了一天的時間溫度終於降到 -80，大功告成囉。