BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2990188 · Received February 6, 2013

    Report

    Report Number
    2016493-2013-00093
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    November 13, 2012
    Report Date
    January 17, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER INFUSION OF INSULIN. A 100ML BAG WITH 100 UNITS/100ML WAS PROGRAMMED IN THE CRITICAL CARE PROFILE TO INFUSE AT 6 UNITS/HOUR BUT THE BAG WAS FOUND EMPTY 2 HOURS LATER. THE CUSTOMER DID NOT PROVIDE ANY ADD¿L PATIENT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50798 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE| ADMINISTRATION SE: MODEL/LOT UNK| ALARIS PC UNIT: SN (B)(4)