BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B.BRAUN/MCGAW 360 INFUSER

    MDR report key: 1170733 · Received September 15, 2008

    Report

    Report Number
    1641965-2008-00070
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K902409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS: SERVICE COULD NOT DUPLICATE THE RATE DISCREPANCY AND THE PUMP PASSED FINAL QC INSPECTION. OUR TESTING IS PERFORMED USING 3CC AND 60CC BD (BECTON DICKINSON) SYRINGES. THE B BRAUN OPERATOR'S GUIDE NOTES THAT ONLY BD PLASTIPAK SYRINGES BETWEEN 3CC AND 60CC ARE RECOMMENDED FOR USE WITH PERFUSOR BASIC PUMPS. B BRAUN CANNOT MAKE ANY CLAIMS TO THE ACCURACY OF DELIVERY OR THE EFFECTIVENESS OF THE OCCLUSION DETECTION SYSTEM USING OTHER SIZES, TYPES AND MANUFACTURERS OF SYRINGES. THE SYRINGE REPORTEDLY USED AT THE HOSPITAL WAS A 30CC BD SYRINGE.

    Description of Event or Problem · 1

    REPORTEDLY, THE INFUSION RATES ARE TOO FAST. IF THE PUMP IS SET FOR 30 MINUTES, IT WILL BE DONE WITHIN 25 MINUTES. THIS WAS TESTED WITH WATER USING A 30CC BD SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B.BRAUN/MCGAW 360 INFUSER SYRINGE PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1