Alerta De Seguridad para Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps

Safety alert

2014-05-05

2014-05-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140505.html

Medical device safety alert: abbott acclaim infusion pumps and hospira acclaim encore infusion pumps the united states food and drug administration (fda) has issued a medical device safety alert concerning abbott acclaim infusion pumps and hospira acclaim encore infusion pumps, manufactured by hospira, inc. the affected abbott acclaim infusion pumps, list number 12032, were manufactured from february 1998 to november 1998 and distributed from september 1998 through february 2004. the affected hospira acclaim encore infusion pump, list number 12237, were manufactured from february 1997 to february 2010 and distributed from july 1999 through november 2013. the manufacturer has received customer reports of broken door assemblies on the abbott acclaim infusion pumps and the hospira acclaim encore infusion pumps. when the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. if the door assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. if the door cannot be closed, the pump cannot be used which can result in a delay of therapy. use of these affected products may cause serious adverse health consequences, including death. the manufacturer recommends users to inspect each hospira/abbott acclaim encore infusion pump for door handle cracks, prior to programming a therapy, by following the steps mentioned in the alert. after following the instructions, if the user determines that a pump has a door that does not close correctly or if free flow is detected while the administration set is in the pump with the door closed, the user should close the roller clamp, remove the pump from clinical service and contact the manufacturer. for details, please refer to the following fda websites: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm395845.Htm http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm395854.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 5 may 2014.