BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATORS

    MDR report key: 8891583 · Received August 14, 2019

    Report

    Report Number
    8010762-2019-00244
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 13, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SAME PRODUCT, SHOWING A SIMILAR MALFUNCTION, HAS BEEN INVESTIGATED IN # (B)(4): WHEN PRIMING WITH WATER, A LEAK WAS DETECTED AT THE POINT CLAIMED BY THE CUSTOMER (POS 5.) 'OPENING FOR HOLDER'. SINCE FURTHER INVESTIGATION ON SAMPLE IS NOT POSSIBLE DUE TO SAFETY REASONS, THE CAUSE OF THE INCIDENT COULD NOT BE IDENTIFIED. IN ADDITION, MAQUET CARDIOPULMONARY GMBH IS AWARE OF SIMILAR FAILURE DESCRIPTION FOR SAME PRODUCT, COMPLAINT # (B)(4). THE VIDEO OF THIS FAILURE ALSO SHOWS THE OXYGENATOR IS LEAKING FROM HOUSING. THUS THE REPORTED FAILURE 'LEAK FROM THE BASE' COULD 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.

    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

    A LEAK WAS OBSERVED IN THE ADAPTER OF THE SUPPORT, BEING NECESSARY THE EXCHANGE OF ALL THE OXYGENATOR. ALL TESTS ON THE DEVICE WERE PERFORMED DURING ASSEMBLY AND THE CIRCULATORY PROCESS BEFORE CPB, AND WERE NOT ALTERED. AS THE PROBLEM OCCURRED MOMENTS BEFORE THE ENTRY INTO CPB, THERE WAS NO DAMAGE TO THE PATIENT, ONLY WAITING A FEW MINUTES FOR OXYGENATOR REPLACEMENT. (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687460 OXYGENATORS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH QUADROX-I ADULT (VKMO) W/ FILTER 92254623

    Patients

    Seq Age Sex Outcome Treatment
    1