Artis Dialysis System 의 안전성 경고

Safety alert

2017-03-06

2017-03-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170306a.html

Medical device safety alert: baxter healthcare artis dialysis system medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its artis dialysis system [product code: 110635 (artis 230v), 115323 (artis 230v physio, and 115962 (artis 230v physio i); software version: 8.09, 8.15, 8.33 and 8.52]. the manufacturer is initiating a field action to update the software version for the above models and software version of artis dialysis system in hong kong. the current version allows for the possibility of resetting and continuing patient treatment without following the instructions for addressing alarm #642, “arterial chamber: level adjustment required.” this will subsequently deactivate the alarm for the remaining treatment time. the reset that follows will predispose patient to venous air embolism. the new software versions prevent the possibility of continuing the treatment without following the instructions for addressing alarm #642, as written in the operator’s manual. deactivation of the alarm #642 for the remaining treatment time following a reset will predispose patient to venous air embolism. there were no adverse events and complaints reported in hong kong that potentially related to this issue. operator may continue to safely use the affected artis dialysis systems while utilizing additional vigilance to adhere to the instructions for use for addressing alarm #642, as documented in the operator’s manual until the software upgrade is completed. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 march 2017.