BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORINGROUP

    MDR report key: 2518155 · Received April 2, 2012

    Report

    Report Number
    2518155
    Event Type
    Other
    Date Received
    April 2, 2012
    Date of Event
    March 28, 2012
    Report Date
    March 30, 2012
    Manufacturer
    SORIN GROUP USA
    Product Code
    JOD
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OVERPRESSURE VALVE ON HEART/LUNG MACHINE BEGAN LEAKING DURING BYPASS RUN. SUCTION LINE STOPPED MOMENTARILY TO REPLACE VALVE. UNK FLUID LOSS DURING LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORINGROUP VA RELIEF CHECK VAL JOD SORIN GROUP USA 1200300126

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR