BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1911427 · Received November 17, 2010

    Report

    Report Number
    9616066-2010-00337
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION CONFIRMED THE HOLE AND LEAK. VISUAL INSPECTION NOTED A SMALL TEAR BELOW THE UPPER FITMENT, MEASURING 0.096 INCHES. MICROSCOPIC EXAM NOTED A CRUSH MARK TO THE UPPER FITMENT. ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SET HAD A HOLE IN THE SILICONE TUBING SECTION NEAR THE UPPER FITMENT AND LEAKED APPROX 100 ML OF POTASSIUM CHLORIDE SOLUTION DURING AN INFUSION. NO ADD'L INFO WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SERIAL NUMBER UNKNOWN