BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6200 PUMP

    MDR report key: 1601031 · Received February 17, 2010

    Report

    Report Number
    6000001-2010-00189
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 23, 2010
    Report Date
    January 25, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF A FLO-GARD 6200 INFUSION PUMP WITH FAILURE CODE 85, WHICH INTERRUPTED A PATIENT INFUSION, CANNOT BE CONFIRMED AS THIS FACILITY IS NOT SENDING THE PUMP TO BAXTER FOR DEVICE EVALUATION OR REPAIR. BAXTER NO LONGER SERVICES FLO-GARD 6200 INFUSION PUMPS. THEREFORE, NO ASSIGNABLE CAUSE CAN BE PROVIDED AND NO REPAIRS WILL BE MADE. SHOULD ANY ADDITIONAL INFORMATION ABOUT THIS EVENT BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD 6200 INFUSION PUMP WITH FAILURE CODE 85, WHICH INTERRUPTED AN INFUSION OF LACTATED RINGER'S SOLUTION ON AN ANIMAL AT AN ANIMAL HOSPITAL. 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 6200 PUMP PUMP, INFUSION FRN UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1