BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 8640384 · Received May 24, 2019

    Report

    Report Number
    8010762-2019-00136
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    April 28, 2019
    Report Date
    June 28, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS, USA (IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002 IMPORTER- MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON- (B)(4). 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

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    FOUND PLASMA LEAK IN OXYGENATOR. COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434117 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH VKMO 70000 92266880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention