BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID ADULT OXYGENATOR WITH SOFTLINE COATING WITH SCREW CONNECTOR

    MDR report key: 10044198 · Received May 11, 2020

    Report

    Report Number
    8010762-2020-00145
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Report Date
    June 26, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K150267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD(DHR)REVIEW RESULT: AFFECTED PRODUCT: BASIC LOT 70137467 AND PACKAGING LOT 70137477 (SERIAL NUMBER (B)(6)). THE AVZ FROM 1555546 TO 1555560 (DMS# (B)(4)) WAS REVIEWED ON 2020-06-26. THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. THE OXYGENATOR WAS INVESTIGATED IN THE LABORATORY ON 2020-06-25. RESULTS OF LABORATORY INVESTIGATION: DURING RINSING OUT SEVERAL CLOTS WERE NOTICED. A INCREASED PRESSURE WAS NOTICED WHEN FLUSHING. AFTER THE SAMPLE WAS CLEANED THREE TIMES THE PRESSURE WAS BACK TO NORMAL VALUES. NO FURTHER ABNORMALITIES WERE NOTICED DURING THE PRESSURE TEST. THUS THE FAILURE COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE IS CLOTTING. ACCORDING TO THE RISK ASSESSMENT (QUADROX-I SMALL ADULT/ADULT, QUADROX-ID ADULT (DMS # 1464420, V15)) FOLLOWING CAUSES CAN LEAD TO CLOTTING: STENOSIS, PROLONGED USE OF OXYGENATOR, NO ANTICOAGULATION OR INSUFFICIENT ANTICOAGULATION, AIR IN SYSTEM (E.G. DUE TO CRACK, IMPAIRED DEAERATION, ACT TO HIGH, HEMOSTASIS, THROMBOZYTOPENIA. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD A FAILED OXYGENATOR. THEY HAD A SIGNIFICANT PRESSURE DROP. THE OXYGENATOR WAS REPLACED DURING PATIENT TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505706 QUADROX-ID ADULT OXYGENATOR WITH SOFTLINE COATING WITH SCREW CONNECTOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HMOD 70000-USA #SQUADROX-ID ADULT O.FILT 70137467

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention