BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGENRATOR, CARDIOPULMONARY BYPASS

    MDR report key: 4736245 · Received April 27, 2015

    Report

    Report Number
    8010762-2015-00403
    Event Type
    Injury
    Date Received
    April 27, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 10, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K102464
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. BASED ON THIS CONFIRMATION OF THE FAILURE BY MANUFACTURER'S LABORATORY, INVESTIGATION IS NOT POSSIBLE. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS, NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I NEONATAL WHICH IS REGISTERED UNDER 510 (K): K102464.

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMER'S INFO: "BAD GAS EXCHANGE PERFORMANCES". PATIENT WEIGHT: (B)(6); PATIENT HEIGHT: (B)(6); PATIENT BSA: 0.54; ARTERIAL BLOOD FLOW: 1500ML/MIN. THE PRODUCT WAS NOT REPLACED DURING TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277064 OXYGENRATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 11000 92125747

    Patients

    Seq Age Sex Outcome Treatment
    1 Other