BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2060651 · Received April 8, 2011

    Report

    Report Number
    9616066-2011-00114
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Report Date
    March 3, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 04/08/2011. (B)(4). DEVICE WAS DISCARDED BY USER BECAUSE IT WAS CONTAMINATED WITH BLOOD. A FAILURE INVESTIGATION COULD NOT BE PERFORMED. THE CAUSE OF THE LEAK IS UNDETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SET HAD A CRACK ON THE TUBING CLOSE TO THE PT. THE NURSE PRIMED SET WITHOUT DIFFICULTY TO GIVE PLATELET INFUSION AND DID NOT NOTE ANY LEAK. BEFORE CONNECTING TO PT, SHE NOTED SMALL PORTION OF TUBING WAS NOT PRIMED. SHE RE-PRIMED, CONNECTED SET TO PT AND STARTED THE INFUSION. WHILE CHECKING TUBING, SHE NOTICED WETNESS NEAR END OF THE SET AND SAW A FEW SMALL AIR BUBBLES INSIDE. SHE ALSO NOTED ABOUT 1.5-2 CM WHITISH LINE - A CRACK AT ABOUT 15 CM LEVEL OF THE TUBING PROXIMAL TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORP. 2477-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR ALARIS PUMP MODULE: SERIAL # UNK| ALARIS PC UNIT: SERIAL # UNK