BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 340946 · Received July 6, 2001

    Report

    Report Number
    6000001-2001-00318
    Event Type
    Other
    Date Received
    July 6, 2001
    Date of Event
    April 29, 2001
    Report Date
    June 7, 2001
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NURSE CLAIMED AN INFUSION PUMP BURNED THE NURSE BUT DID NOT NOTICE IT UNTIL THE NURSE GOT HOME AFTER THE SHIFT. THE AREA AFFECTED IS APPROXIMATELY 1" BY 3" DISCOLORED BUT NO BLISTER EVIDENT 1 DEGREE BURN. ALOE WAS APPLIED AND AREA CLEANED WITH PEROXIDE. FLANAZINE 1% APPLIED WITH SULFA AND A DRESSING WAS SECURED. THE PUMP WAS NOT REMOVED FROM SERVICE AND THE SERIAL NUMBER WAS NOT RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30397 COLLEAGUE VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) COLLEAGUE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other