Alaris PC Unit, Model 8015 의 안전성 경고

Safety alert

2012-08-02

2012-08-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120802.html

Medical device safety alert: carefusion alaris pc unit, model 8015 the united states food and drug administration (fda) issued a class i recall concerning alaris pc unit, model 8015 (part of the alaris electronic infusion pump), manufactured by carefusion 303, inc. the affected unit had power supply board p/n tc 10005122 which were manufactured after january 2011 and were distributed from 1 january 2011 to 31 may 2012. according to fda, a component on the pc unit power supply board is causing an error code (120.4630): "system error" or "missing battery error" to occur. the error code is accompanied by both an audible alarm and a visual error message on the pc unit screen. if the error code occurs at start-up, the alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. if the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient. for details, please refer to fda website http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm314090.Htm and http://www.Fda.Gov/medicaldevices/safety/ listofrecalls/ucm314019.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 2 august 2012.