BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR

    MDR report key: 2220374 · Received August 11, 2011

    Report

    Report Number
    2220374
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 11, 2011
    Manufacturer
    TERUMO
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE DISPOSABLE OXYGENATOR DID NOT FAIL COMPLETELY, BUT WAS FUNCTIONING AT SUBOPTIMAL PERFORMANCE. TANDEM BYPASS WAS REQUIRED TO CORRECT OXYGENATION WHILE ON BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGENATOR DISPOSABLE OXYGENATOR DTZ TERUMO SX25RX *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR