BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1522742 · Received November 4, 2009

    Report

    Report Number
    2016493-2009-00176
    Event Type
    Death
    Date Received
    November 4, 2009
    Date of Event
    October 8, 2009
    Report Date
    October 9, 2009
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 11/03/2009. THE INVOLVED PUMP AND EVENT LOGS WERE RECEIVED FOR INVESTIGATION. THE REPORTED EVENT OF OVER INFUSION OF MORPHINE COULD NOT BE CONFIRMED OR DUPLICATED. THE PUMP WAS TESTED FOR RATE ACCURACY AT THE INCIDENT RATE OF 10ML/HR, AND WAS FOUND TO BE INFUSING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MORPHINE 50MG IN A 250ML BAG WAS PROGRAMMED TO INFUSE AT 2MG/HOUR. THE ENTIRE BAG INFUSED IN 15 MINUTES. THE PATIENT DIED. THE RELATIONSHIP, IF ANY, BETWEEN THE PATIENT DEATH AND THE PUMP IN USE, AT THE TIME OF THE EVENTS, HAS NOT BEEN CONFIRMED BY THE FACILITY. THE CUSTOMER DID NOT PROVIDE THE PATIENT'S CAUSE OF DEATH.

    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 UNK Death