BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1062660 · Received June 11, 2008

    Report

    Report Number
    6000001-2008-00371
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: THE REPORTED CONDITION OF THE INACCURACY WAS NOT DUPLICATED OR CONFIRMED. THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTS PRIOR TO CUSTOMER RETURN.

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL TECHNICIAN REPORTED, "SECONDARY SET TO RUN AT 999ML PER HOUR/PRIMARY 150ML PER HOUR. WHEN CHECKED PRIMARY WAS RUNNING AT 999ML" DURING PT USE. ON JUNE 9, 2008, THE FACILITY'S IMPROVEMENT PROFESSIONAL REPORTED THAT A MALE EMERGENCY DEPT PT OF UNK AGE AND UNK WEIGHT, WAS ADMITTED IN 2008. THE ADMITTING DIAGNOSIS WAS UNK. THE PT WAS ADMINISTERED A 1 LITER PRIMARY INFUSION OF NORMAL SALINE (NS) CONTAINING 10 MILLIEQUIVALENTS OF POTASSIUM THAT WAS STARTED AT 1440 ON ADMISSION. THE PRIMARY RATE WAS SET TO INFUSE AT 150 ML/HR. THE 100 ML SECONDARY INFUSION OF PROTONIX (ACID REFLUX) WAS SET TO INFUSE AT 999 ML PER HOUR. THE FACILITY REP STATED THE NURSE ENTERED THE ROOM AFTER 45 MINUTES AND NOTICED THAT THE PRIMARY INFUSION OF NS WAS INFUSING AT 999 ML/HR. THE INFUSION WAS PIGGYBACKED ABOVE THE LEVEL OF THE PUMP, THE INFUSION WAS NOT RUNNING USING GRAVITY. THE PRODUCT CODE AND LOT OF THE TUBING WAS NOT AVAILABLE. IT IS UNK IF THE BLUE HANGER WAS USED FOR THE INFUSION. ADD'L LABS WERE ORDERED, BUT THE CARE TO THE PT DID NOT CHANGE. THE PT WAS DISCHARGED. 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 (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1