Prismaflex Control Unit 의 안전성 경고

Safety alert

2018-05-07

2018-05-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180507b.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 and serial numbers as below: product: 1) prismaflex 4.11; 2) prismaflex 5.00 row; 3) prismaflex 6.10 row; 4) prismaflex 7.11; 5) prismaflex 7.Xx row; 6) prismaflex system serial number: all the manufacturer will be installing new firmware on all prismaflex control units to address for the units to exhibit a failure mode with the pump module electronics. the failure mode may result in a “voltage out of range” malfunction alarm, which causes the device to enter a “safe state” and become inoperable until it is serviced. according to the manufacturer, the “voltage out of range” malfunction alarm causes the prismaflex control unit to enter a “safe state” by stopping all pumps and closing the return line clamp. this failure mode can occur at any time during use and may result in an interruption and/or delay in therapy. patient harm is not expected as the blood may be manually return to the patient. according to the local supplier, there were no associated adverse events, patient injury and product complaints reported in hong kong. the manufacturer advises that operators may continue to safely use prismaflex control units that have not exhibited the “voltage out of range” malfunction alarm. the manufacturer will be releasing new firmware that will prevent the malfunction from occurring. 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 7 may 2018.