BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSITIONAL TUBING

    MDR report key: 975847 · Received May 7, 2007

    Report

    Report Number
    975847
    Event Type
    Malfunction
    Date Received
    May 7, 2007
    Date of Event
    February 5, 2007
    Report Date
    February 20, 2007
    Manufacturer
    TERUMO-ANN ARBOR
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RUPTURE OF TUBING IN RACEWAY OF HEART LUNG MACHINE OCCURRED WHILE ON CPB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSITIONAL TUBING CARDIO PULMONARY BYPASS TUBING PACK DQO TERUMO-ANN ARBOR * GM02

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR