Advanced Perfusion System 1 의 안전성 경고

Safety alert

2012-09-14

2012-09-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120914.html

Medical device safety alert: silicone tracheostomy tubes medical device manufacturer, terumo cardiovascular systems (cvs) has issued a field safety corrective action regarding the recall of flow module for terumo advanced perfusion system 1 [catalogue no.: 802018; serial number range: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, 00823-00847. the manufacturer received two reports of random flow readings and/or intermittent false back flow alarms for the terumo advanced perfusion system 1 when there was no tubing in the flow sensor. when operating as intended, the module will generate '---' (three dashes) in the display, and issue a ‘check sensor’ alert message, when there is no tubing in the flow sensor. the manufacturer’s investigation found that: the malfunction was caused by an improperly set voltage level in a population of circuit boards used in the flow modules for terumo system 1. the module operates correctly if tubing is installed. this failure of the flow module is expected to occur very rarely in the affected population and is easily detectable. besides, the failure only occurs when there is no tubing installed in the flow sensor and therefore the only risk to the patient is if the failure results in operator confusion, distraction or a delay of surgical procedure. there are no known reports of patient injury as a result of this issue. the manufacturer has decided to replace all flow modules in the affected population. users can continue to use their flow modules while awaiting replacement. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 september 2012.