BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONDUCER CARDIOPLEGIA SETS

    MDR report key: 1942113 · Received November 11, 2010

    Report

    Report Number
    1828100-2010-02082
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 17, 2010
    Report Date
    November 11, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED WATER LEAKED FROM THE CONDUCER GROMMETS. ONLY A FEW DROPLETS OF WATER LEAKED, SO THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONDUCER CARDIOPLEGIA SETS WATER SUPPLY BRACKET CONDUCER DTR TERUMO CARDIOVASCULAR SYSTEMS CORP. 4979

    Patients

    Seq Age Sex Outcome Treatment
    1