BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1033038 · Received April 22, 2008

    Report

    Report Number
    6000001-2008-00263
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVAL, A FOLLOW-UP REPORT WIL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH A CONDITION OF "SHUTS DOWN WITH SYSTEM FAILURE". THIS CONDITION OCCURRED DURING BIO-MED TESTING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REP. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1