BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLO-GARD 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 294667 · Received September 5, 2000

    Report

    Report Number
    6000001-2000-00503
    Event Type
    Death
    Date Received
    September 5, 2000
    Date of Event
    August 2, 2000
    Report Date
    August 7, 2000
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PUMP WAS SET TO INFUSE A 150ML BAG OF MORPHINE AT 1ML/HR. IT INFUSED 150ML IN LESS THAN 3 HRS. PT EXPIRED. THE PT INVOLVED WAS IN END-STAGE RENAL FAILURE, AND WAS BEING DIALYZED WHILE RECEIVING A MORPHINE DRIP. THE HOSP BIOMED. WAS ABLE TO RUN A PRELIMINARY ACCURACY TEST AT 1ML/HR FOR ONE HOUR, AND THE PUMP PASSED. THE HOSP BIOMED. WANTS TO PERFORM A 15-HOUR TEST, BUT THE PUMP WAS TAKEN AND BEING HELD BY THE MEDICAL EXAMINER. THE PUMP WAS TO BE SENT TO A THIRD PARTY FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. 6301 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death