BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE ADMINISTRATION SET

    MDR report key: 1892549 · Received November 3, 2010

    Report

    Report Number
    9616066-2010-00315
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 29, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 11/03/2010. (B)(4). PRODUCT EVALUATED AND THE CUSTOMER'S EXPERIENCE OF THE TUBING BREAKING OFF AT THE BOTTOM OF THE ACCUSLIDE WAS CONFIRMED. THE SET WAS OBSERVED TO BE SEPARATED BETWEEN THE OUTLET PORT OF THE ACCUSLIDE AND THE PVC TUBING. THE PVC TUBING RUPTURED AND SEPARATED. A PORTION OF THE PVC TUBING REMAINS INSIDE THE OUTLET PORT OF THE ACCUSLIDE. THE ROOT CAUSE OF THIS SEPARATION WAS NOT IDENTIFIED AND IS CONSIDERED TO BE AN ISOLATED OCCURRENCE. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE MFG DATABASE WAS REVIEWED; NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD PERIOD OF THIS MODEL FOR THE FAILURE MODE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TUBING BROKEN OFF AT THE JOINT WITH THE BOTTOM OF THE CASSETTE. THE REPORT CAME FROM (B)(6) AND APPEARS THE TUBING WAS USED FOR TPN AS EVIDENCED BY THE ODOR. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE ADMINISTRATION SET FPA CAREFUSION CORPORATION 72323E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK