BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 7553309 · Received May 30, 2018

    Report

    Report Number
    8010762-2018-00192
    Event Type
    Death
    Date Received
    May 30, 2018
    Date of Event
    May 8, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4). (B)(6). MAQUET CARDIOPULMONARY (B)(4) RECEIVED THE QUADROX-I ADULT BACK. THE PATTERN WAS CONTAMINATED. THE SAMPLE WAS CLEANED WITH SODIUM HYPOCHLORITE. NO ABNORMALITIES WERE FOUND DURING VISUAL INVESTIGATION. A FURTHER INVESTIGATION IS CURRENTLY NOT POSSIBLE FOR SAFETY REASONS. CORRESPONDING MEASURES HAVE ALREADY BEEN INITIATED. ONCE THESE MEASURES IMPLEMENTED, THE INVESTIGATION CAN BE RESUMED. THE FAILURE COULD NOT BE CONFIRMED BY LABORATORY. SAP TREND SEARCH WAS PERFORMED (MATERIAL 70105.3164, SIMILAR FAILURE) WHICH CAME TO FOLLOWING RESULTS: 0 COMPLAINTS WERE RECORDED IN LAST 12 MONTHS. BASED ON THE SALES FIGURES OF THE LAST (B)(4) MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED: (B)(4), WHICH IS BELOW (B)(4). DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. AFFECTED PRODUCT: BASIC LOT: 70116988 AND PACKAGING LOT :70116987 (SERIAL NUMBER (B)(4)). THE AVZ FROM (B)(4) WAS REVIEWED. THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. FURTHER INVESTIGATION STEPS ARE MOMENTARILY NOT POSSIBLE TO BE EXECUTED DUE TO WORK SAFETY ISSUES IN THE COMPLAINT LABORATORY. MAQUET CARDIOPULMONARY IS CURRENTLY IN THE MITIGATION OF THIS ISSUE. WHEN FURTHER INVESTIGATION STEPS CAN BE EXECUTED AGAIN, THESE INVESTIGATIONS WILL BE PERFORMED AND THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY. THUS THE MOST PROBABLE CAUSE OF THE REPORTED EVENT REMAINS UNCLEAR AT THIS TIME.

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE HAS NOT BEEN RETURNED YET. REFERENCE EXEMPTION # E2018002. (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: "ON (B)(6), TRAUMA PATIENT WAS PUT ON ECMO AT THE EMERGENCY DEPARTEMENT. THE PATIENT'S AORTA WAS PIERCED BY A RIB, THIS CAUSED MASSIVE BLEEDING. ALTHOUGH THE MASSIVE BLEEDING THEY PUT THE PATIENT ON ECMO. THE DEAD OF THE PATIENT WAS NOT CAUSED BY OUR PRODUCT QUADROX ID BUT THE HEAD OF PERFUSION WANT US, GETINGE-MAQUET TO INVESTIGATE AND DEMANDS A PERFORMANCE TEST OF THE OXYGENATOR. PRODUCT IS AVAILABLE FOR INVESTIGATION." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394949 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BE-HQV 30517 92226452

    Patients

    Seq Age Sex Outcome Treatment
    1 Death