Prismaflex Control Unit 의 안전성 경고

Safety alert

2017-02-23

2017-02-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170223.html

Medical device safety alert: baxter healthcare prismaflex control unit medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its prismaflex control unit, details product models, serial numbers and software versions as below: product models: 1) prismaflex system; 2) prismaflex 4.11; 3) prismaflex 5.00 row; 4) prismaflex 6.10 row; 5) prismaflex 7.Xx row serial numbers: all software versions: 1) 4.10, 6.1 0, 7.10 & 7.11; 2) 4.10, 6.10, 7.10 & 7.11; 3) 6.10 & 7.10; 4) 6.10 , 7.10 & 7.11; 5) 6.10 , 7.10 & 7.11 the manufacturer has received reports of device operators failing to adhere to the instructions for use pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. if not followed, severe blood loss may occur with a potentially fatal outcome. according to the manufacturer, unloading of the disposable set without following the instructions and warnings on the prismaflex control units may lead to severe blood loss and potentially fatal outcomes. according to the local supplier, there were no adverse events and complaints reported in hong kong that potentially related to this issue. the manufacturer advises that operators may continue to safely use the affected units by following the instructions provided in the prismaflex operator’ s manual and the on-screen instructions when unloading the disposable set. specifically, operators should ensure that all lines are clamped and the patient is disconnected before proceeding with unloading. the manufacturer will be releasing an updated software version that will take additional measures to further ensure patient safety. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 23 february 2017.