BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-I OXYGENATOR

    MDR report key: 3902579 · Received May 9, 2014

    Report

    Report Number
    8010762-2014-00204
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOVASCULAR (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE INITIATION OF BY-PASS, THE DEVICE HAD TO BE CHANGED DUE TO A LEAKY LUER-LOCK TEMPERATURE CONNECTION PORT. SURGERY WAS PROLONGED AN ADDITIONAL 15 MINUTES. THERE WAS NO REPORTED PATIENT EFFECT. REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282246 QUADROX-I OXYGENATOR MICROPOROUS MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70089838

    Patients

    Seq Age Sex Outcome Treatment
    1