BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM XL3M MICRO/MARCRO PUMP

    MDR report key: 539875 · Received August 10, 2004

    Report

    Report Number
    2921482-2004-00468
    Event Type
    Death
    Date Received
    August 10, 2004
    Date of Event
    July 14, 2004
    Report Date
    July 19, 2004
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "TPN WAS INFUSING AT 60CC/HR ON A TRIPLE PLUM PUMP. THE PUMP ALARMED "AIR IN LINE" AND THE NURSE FOUND THE PT TO BE EXPERIENCING A GRAND MAL SEIZURE IN 2004. THE PUMP SETTINGS WERE FOUND TO BE: VOLUME TO BE INFUSED 482CC, TOTAL VOLUME INFUSED 1841CC, RATE 999CC/HR. THE 2ND PUMP WAS EMPTY AND OFF. THE 3RD PUMP HAD 1/2NS AT 25CC/HR. THE PT WS RESUSCITATED BUT DIED SAME DAY AT 0845. IN 07/2004 AT 2200, CHANNEL A WAS PROGRAMMED TO DELIVER TPN AT A RATE OF 60 ML/HR WITH A VOLUME TO BE INFUSED OF 1000 ML. THE TOTAL VOLUME OF TPN IN THE SOLUTION BAG WAS 1540 ML. IN 2004 AT 0035, THENURSE ENTERED THE PT'S ROOM TO RESPOND TO AN AIR IN LINE ALARM AND ABSERVED THAT THE "TPN BAG AND THE TUBING PROXIMAL TO THE PUMP WERE EMPTY." AT THAT TIME, "THE PT WAS HAVING A GRAND MAL SEIZURE THAT LASTED APPROXIMATELY 3 MINUTES." THE PT HAD NO SPONTANEOUS REPIRATIONS. CPR WAS STARTED. THE PT WAS TREATED WITH AN UNSPECIFIED DOSE OF EPINEPHRINE AND WAS INTUBATED. UNSPECIFIED DOSES OF DOPAMINE AND LEVOPHED WER ALSO INITIATED. THE PT CNTINUED TO HAVE "NO SPONTANEOUS RESPIRATIONS," WAS "HYPOTENSIVE" AND REPORTELY HAD "NO NEUROLOGICAL RESPONSE." THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. ON THE MORNING OF 2004, TH PT'S FAMILY REQUESTED WAS REPORTEDLY GRANTED AND WITHIN "MINUTES," THE PT EXPIRED. THE TIME OF DEATH WAS REPORTED TO BE 0845. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XL3M MICRO/MARCRO PUMP INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death TPN, COMPOUNDED BY THE USER FACILITY.