BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1923318 · Received November 19, 2010

    Report

    Report Number
    9616066-2010-00334
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 11/19/2010. (B)(4). PRODUCT EVALUATED AND CUSTOMER'S REPORT OF LEAKING OF THE TUBING SET WAS CONFIRMED, HOWEVER, ONLY ONE LEAK WAS OBSERVED ON THE RETURNED SET AND NOT TWO AS INITIALLY REPORTED. THE LEAK WAS OBSERVED TO BE DUE TO THE SILICONE TUBING HAVING A SMALL TEAR BELOW THE UPPER BLUE FITMENT. THE TEAR WAS MEASURED TO BE 0.0825 INCHES. A CRUSH MARK WAS NOTED TO THE UPPER BLUE FITMENT. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE SET WAS BUILT BETWEEN (B)(4) 2010 AND (B)(4) 2010. THE ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TUBING HAS TWO LEAKS ALONG THE LINES. DATE ON MEDWATCH IS DATE PRODUCT CAME TO RISK MANAGEMENT, NOT DATE OF EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK