BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2121142 · Received May 4, 2011

    Report

    Report Number
    9616066-2011-00160
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2011. (B)(4). ALTHOUGH REQUESTED, THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED. THE CAUSE OF REPORTED LEAK IS UNKNOWN.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED CUSTOMER INFORMATION RECEIVED OF LEAKING FROM DRIP CHAMBER AIR VENT. NO OTHER EVENT OR CLINICAL INFORMATION PROVIDED. THERE WAS NO REPORT OF MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0500 10115495

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN