Retiro De Equipo (Recall) de Device Recall BodyGuard

Recall

70294

Class 2

Z-1126-2015

2015-01-16

2015-02-19

Terminated

United States

2017-03-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132890

Cme america is recalling the bodyguard and bodyguard 323 infusion pumps due to the potential for an over delivery.

CME America sent an "Urgent Medical Device Recall" letter dated January 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users: To date there have been no reports of adverse events or serious injury. However, there is the potential for serious injury or death. CME America recommends that you DO NOT use the BodyGuard 323 pump for PCA infusion. If your devices are currently in use, be sure that the programmed parameters DO NOT involve a patient controlled bolus dose less than 0.1 miln volume (translated into meg or mg). Follow-up Actions by CME America: CME America has identified the root cause of this issue and is recommending installation of a new version of software, USA36B4, for affected BodyGuard 323 infusion pumps. This software is identical to the previously released version, USA36A4.2. However the designation of B4 in the software name will identify updated software in each device. CME America will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Your assistance is appreciated and necessary to prevent use and facilitate remediation of the recalled product. CME America can address any questions regarding the recalled product by calling the CME America recall line at 720-839-2391.