BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1671941 · Received April 28, 2010

    Report

    Report Number
    2016493-2010-00428
    Event Type
    Death
    Date Received
    April 28, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 31, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVENT LOGS WERE SUBMITTED FOR REVIEW, WHICH SHOWED THAT THE USER SELECTED GUARDRAILS TO PROGRAM AN INFUSION OF HEPARIN; THE WEIGHT-BASED OPTION WAS CHOSEN, THE PROGRAMMED PARAMETERS WERE 2500 UNITS IN 250 ML, 350 UNITS/KG/H. PT WEIGHT AND VTBI WERE ENTERED, AND A GUARDRAILS ALERT INDICATED THAT THE DOSE EXCEEDED THE GUARDRAILS LIMIT OF 30 UNITS/KG/H. THE USER PROCEEDED AND STARTED THE INFUSION. THE INFUSION RAN AT 35 ML/H FOR APPROX 5 HOURS BEFORE THE PUMP WAS TURNED OFF.

    Description of Event or Problem · 1

    OVER INFUSION OF HEPARIN; THE INTENDED INFUSION WAS 25,000 UNITS IN 250 ML TO RUN AT 350 UNITS PER HOUR (3.5 ML/H).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ALARIS PC UNIT: (B) (4)