BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATORS

    MDR report key: 8891587 · Received August 14, 2019

    Report

    Report Number
    8010762-2019-00248
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH WAS NOT REQUESTED THE PRODUCT BACK FOR INVESTIGATION SINCE THE ISSUE IS KNOWN. MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCT, SHOWING A SIMILAR MALFUNCTION, HAS BEEN INVESTIGATED IN #:703007163: LEAK TEST OF THE BLOOD SIDE WAS PERFORMED. A STRONG LEAK FROM THE GAS OUTLET WAS DETECTED. NO FURTHER ABNORMALITIES COULD BE DETECTED. A LEAK CAN BE CONFIRMED. FURTHER INVESTIGATION STEPS ARE MOMENTARILY NOT POSSIBLE TO BE EXECUTED DUE TO WORK SAFETY ISSUES IN THE COMPLAINT LABORATORY. THEREFORE NO EXACT ROOT CAUSE COULD BE DETERMINED. ACCORDING TO THE RISK FILES THE INCREASING PRESSURE COULD BE CAUSED THE ISSUE AND FIBERS OF THE OXYGENATOR COULD BE DAMAGED DUE TO THIS. THEREFORE LIQUID LEAK WAS DETECTED AT GAS OUTLET. 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.

    Description of Event or Problem · 0

    COMPLAINT#: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AFTER 30 MINUTES BLOOD AT THE GAS OUTLET OF THE OXYS FROM HMT SET. COMPLAINT NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687260 OXYGENATORS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH QUADROX-I ADULT 92252358

    Patients

    Seq Age Sex Outcome Treatment
    1