BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2113614 · Received May 24, 2011

    Report

    Report Number
    2016493-2011-00336
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    February 26, 2011
    Report Date
    April 25, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS WERE MADE TO OBTAIN THE LOGS, NO LOGS WERE SENT BY THE FACILITY AND THEREFORE NO INVESTIGATION COULD BE PERFORMED. ROOT CAUSE OF THE REPORTED EVENT IS UNK. A F/U REPORT WILL BE SUBMITTED IF LOGS RECEIVED AT A LATER DATE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 24 HOUR CHEMO INFUSIONS LASTING LONGER. AN INFUSION WAS STARTED AT 6:50 PM AND PROGRAMMED CISPLATIN (COMBINATION WITH CYCLOPHOSPHAMIDE) 22 MG/321 ML AT 13.4 ML/HR AND DOXORUBICIN 22 MG/511 ML AT 21.29 ML/HR. THE INFUSION BAG WAS FOUND TO HAVE A RESIDUAL VOLUME REMAINING IN BOTH BAGS REQUIRING ADD'L HOURS FOR INFUSION. CUSTOMER STATES NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT - (B)(4)| (DATE OF TX (B)(6) 2011)