BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3T MEDICAL SYSTEMS, LLC

    MDR report key: 389731 · Received April 15, 2002

    Report

    Report Number
    MW1024774
    Event Type
    Malfunction
    Date Received
    April 15, 2002
    Date of Event
    March 27, 2002
    Report Date
    April 15, 2002
    Manufacturer
    GENEVA MEDICAL PRODUCTS
    Product Code
    KRI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A DEFECTIVE 3T VENT VALVE WAS VERBALLY COMMUNICATED TO THE 3T CORPORATE OFFICE. A VENT VALVE IS A ONE-WAY VALVE USED IN A BLOOD LINE DURING OPEN HEART SURGERY. THE DEFECTIVE VALVE LEAKED A SMALL QUANTITY OF BLOOD AS AN ADDED COMPONENT TO A CUSTOM TUBING PACK MFG AND DISTRIBUTED BY MEDTRONIC, INC. A PRIOR "OUT OF THE BOX" FAILURE OCCURRED AT THE SAME HOSP PRIOR TO USING A SIMILAR DEVICE SOLD BY 3T THAT LEAKED CLINICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3T MEDICAL SYSTEMS, LLC ONE-WAY VENT VALVE KRI GENEVA MEDICAL PRODUCTS * 7167789

    Patients

    Seq Age Sex Outcome Treatment
    1 * THE DEFECTIVE VENT VALVES WERE INSTALLED IN CUSTOM| TUBING PACKS #1P82R3 MAN.