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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 179 08 13 000
Date submitted: 8/28/2013
Manufacturer:Codman & Shurtleff Inc
Device Type:Infusion pump , MedStream Programmable Infusion System
Description:MedStream Programmable Infusion System
Medical Device Identifier:91-4200 MedStream Programmable Pump; 20mL 91-4201 MedStream Programmable Pump; 40mL 91-4289 MedStream Refill Kit 91-4290 MedStream Refill Kit; 6 pack
Reason of Field Safety Corrective Action:An on-going investigation into complaints for increased drug flow rates exceeding programmed flow rates revealed the possibility that air introduced into the pump reservoir during filling/re-filling can result in air bubble expansion which can cause increased expulsion of drug into the patient when the valve opens.
Remedy Action:Although it is technically not feasible to definitively identify this condition in returned complaint pumps, this is a theoretical risk (that was inducible in laboratory settings) Note that the current instructions for use state that air should be expelled from the refill system prior to injecting medication into the pump. A corrective action is being taken by issuance of a Field Safety Notice to alert users to the possibility that inadvertent injection of air into the drug pump reservoir/flow path could result in a fast flow occurrence which could result in over-dosing of patients. Instructions for Use and other product materials and training support for the pumps and refill kits are to be updated to assure that this warning is available for users.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY , Riyadh , (011) 4142200
Report Source:NCAR
Source Ref. Number:CH-2013-08-26-076
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments