BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2251744 · Received August 31, 2011

    Report

    Report Number
    9616066-2011-00499
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 15, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER STATES THAT THE SET WILL BE RETURNED FOR INVESTIGATION. UPS LABEL PROVIDED FOR PRODUCT RETURN. ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CHECK VALVE FAILURE WITH FLUID VISUALIZED GOING FROM SECONDARY BAG INTO PRIMARY BAG EVEN THOUGH THE HEAD HEIGHT DIFFERENTIAL WAS CORRECT. THE PATIENT WAS RECEIVING METHOTREXATE CHEMO. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2126-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO