BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1526580 · Received November 13, 2009

    Report

    Report Number
    6000001-2009-01171
    Event Type
    Malfunction
    Date Received
    November 13, 2009
    Date of Event
    October 1, 2009
    Report Date
    November 3, 2009
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD., SINGAPORE 2573
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WHICH CHEWED UP THE TUBING AND INTERRUPTED A PATIENT INFUSION CANNOT BE CONFIRMED AS THIS FACILITY IS NOT SENDING THE PUMP TO BAXTER FOR DEVICE EVALUATION OR REPAIR. THEREFORE, NO ASSIGNABLE CAUSE CAN BE PROVIDED AND NO REPAIRS WILL BE MADE.SHOULD THE PUMP BE RECEIVED FOR EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WHICH CHEWED UP THE TUBING AND INTERRUPTED AN INFUSION OF RITUXAN ON A (B) (6) MALE PATIENT IN THE FACILITY'S INFUSION SUITE. THE INTENDED INFUSION WAS 500ML OF RITUXAN OVER A 6 HOUR PERIOD. THE PUMP WAS SWAPPED OUT AND THE INFUSION RESUMED ON ANOTHER DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE PTE. LTD., SINGAPORE 2573

    Patients

    Seq Age Sex Outcome Treatment
    1 58