BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3132850 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00323
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 23, 2013
    Report Date
    April 1, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MFR. ALTHOUGH REQUESTED, THE SET HAS NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE SET BE REC'D FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A SECONDARY ANTIBIOTIC WAS SEEN BACKING UP INTO THE PRIMARY BAG. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191087 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10015048 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE, SN UNK