BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 107167 · Received July 17, 1997

    Report

    Report Number
    6000001-1997-00845
    Event Type
    Malfunction
    Date Received
    July 17, 1997
    Date of Event
    June 1, 1997
    Report Date
    June 17, 1997
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS PROGRAMMED TO INFUSE A 250 ML NTG SOLUTION AT 1.5 ML/HR. AFTER 15 HRS IT WAS NOTED THAT THE SOLUTION CONTAINER WAS EMPTY. THE INFUSION PUMP WAS REMOVED FROM THE PT. THE PT SHOWED NO ILL EFFECTS. NO ADD'L PT INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN