BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 8599331 · Received May 10, 2019

    Report

    Report Number
    8010762-2019-00125
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 11, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH WAS NOT REQUESTED THE PRODUCT AT FIRST SINCE FAILURE COULD BE ALREADY KNOWN TO MANUFACTURER. THE INFORMATION WAS REQUESTED THREE TIMES AND NO RESPONSE WAS RECEIVED. THE MEANINGFUL DHR REVIEW COULD NOT BE PERFORMED SINCE THE SERIAL NUMBER OF PRODUCT WAS NOT AVAILABLE. TREND SEARCH WAS PERFORMED AND NO SYSTEMIC ISSUE COULD BE DETERMINED. THE REPORTED FAILURE DID NOT CONTRIBUTE TO DEATH OR SERIOUS INJURY. AT THIS TIME NO SIMILAR COMPLAINT INVESTIGATED WAS FOUND WHICH COULD LED TO THE CONFIRMATION OF THE FAILURE AND / OR A PRODUCT RELATED MALFUNCTION. THUS THE FAILURE COULD NOT BE CONFIRMED. THIS COMPLAINT IS BEING MONITORED AS PART OF THE COMPLAINT DATA TRENDING OF MAQUET CARDIOPULMONARY GMBH AND FURTHER INVESTIGATIONS AND MEASURES WILL BE CONDUCTED IN CASE OF ADVERSE TRENDING.

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). DEVICE NOT RETURNED. REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    REF.: # (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: "INFORMATION FOR LEAKAGE OF LIQUIDS, LEAKAGE DURING USE". REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393038 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH VKMO 71000 92230622

    Patients

    Seq Age Sex Outcome Treatment
    1