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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 101 03 12 000
Date submitted: 3/25/2012
Manufacturer:Hospira Inc
Device Type:Infusion pump, GemStar Bolus Cord
Description:Infusion pump, Bolus Cord, delivery
Medical Device Identifier:List Number 13027 Serial no.: All Lot/batch no.: All
Reason of Field Safety Corrective Action:Hospira, Inc. has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord. Potential risk due to failure of the bolus cord is the potential for an unrequested bolus delivery or the failure to deliver requested medication to the patient. The amount of unrequested delivery will be limited by programming lockout volumes. An unrequested narcotic delivery may cause over sedation requiring possible medical intervention, but is unlikely to result in serious or life threatening injuries. The failure to deliver requested narcotic medication may result in the lack of adequate pain relief.
Remedy Action:Do not twist or bend the cord or connector. You should refer to the Technical Service Manual for proper inspection of your existing cords. Below are excerpts from the service manual for your convenience (attached)
Athorized Representative/Importer/Distributor:AL-KAMAL Import, Riyadh, (01) 2181122
Report Source:NCAR
Source Ref. Number:CA-2012-03-19-002
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Hospira Inc.pdf