Heater Cooler Device 의 안전성 경고

Safety alert

2014-08-07

2014-08-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140807b.html

Medical device safety alert: sorin heater cooler device medical device manufacturer, sorin, has issued a field safety notice (fsn) concerning its heater cooler device. during the investigation work on some cardiac surgery patients infected with a slow growing mycobacterium chimaera, it has been identified that some hospitals’ heater cooler devices are contaminated. the manufacturer advises users that they can continue to safely use the heater cooler devices in accordance with the operator’s manual. it also recommends users of the followings: review information in fsn to assure that users are aware of proper water management in cardiac surgery theatre. specifically, assure that users understand mycobacteria and the potential contamination risks for cardiac surgeries as mentioned in the fsn. review heater cooler operating practices and cardiac surgery theatre water management practices. also evaluate heater cooler device(s) for potential contamination. refer to the heater cooler device operator’s manual and/or information in fsn, and review the necessary disinfection practices to assure practices are aligned with the directions. if users are concerned that vigilance to the operating instructions may be in question, perform microbiological sampling of the water in heater cooler device, disinfect the device and determine if decontamination is necessary. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 7 aug 2014.