BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3023251 · Received February 27, 2013

    Report

    Report Number
    9616066-2013-00133
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE SET BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    THE NURSE CLINICIAN REPORTED A BACK CHECK VALVE FAILURE. DETAILS OF THE EVENT WERE REPORTED AS FOLLOWS: DOXORUBICIN INFUSING AS A SECONDARY WAS NOTED TO BE BACKING UP IN THE PRIMARY TUBING PAST THE BACK CHECK VALVE ABOUT 20 HOURS INTO THE INFUSION. THE FAILURE WAS NOTICEABLE BECAUSE DOXORUBICIN IS RED. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84754 TALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK| ALARIS SECONDARY SET, MODEL 11448967, LOT UNK| ALARIS PUMP MODULE, SN UNK