BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATORS

    MDR report key: 8811157 · Received July 22, 2019

    Report

    Report Number
    8010762-2019-00220
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    June 20, 2019
    Report Date
    August 27, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAP AND OT TREND SEARCH HAS BEEN PERFORMED FOR COMPONENT QUADROX-I,ID ,IR : 7 ADDITIONAL COMPLAINT WERE RECORDED IN LAST 12 MONTHS. RECENT SALES FIGURES TIME FRAME 06/2018-05/2019: (B)(4) PIECES. OCCURRENCE RATE: (B)(4). DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. THE DHR REVIEW OF OXYGENATOR IS PERFORMED UNDER TASK CHILD RECORD #(B)(4). RESULT: NO ABNORMALITY WAS FOUND. DHR REVIEW OF FINISH PRODUCT RESULT: THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. 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 #703007198: VISUAL INSPECTION AND LEAK TEST ACCORDING TO LV 201 WERE PERFORMED. DURING LEAK TEST, A CRACK WAS DETECTED AT BLOOD INLET. BASED ON THIS FAILURE COULD 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. 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. IMPORTER- (B)(4).

    Description of Event or Problem · 1

    A LEAK OCCURRED FROM THE VENOUS BLOOD INLET PORT DURING PRIMING. A FINE CRACK WAS SEEN. NO HEALTH DAMAGE TO PATIENTS. COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607895 OXYGENATORS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH QUADROX-I ADULT (VKMO) W/ FILTER 70121518

    Patients

    Seq Age Sex Outcome Treatment
    1