BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 7965302 · Received October 15, 2018

    Report

    Report Number
    8010762-2018-00277
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 24, 2018
    Report Date
    December 13, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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 (B)(4). RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- (B)(4). CONTACT PERSON- (B)(6). MAQUET CARDIOPULMONARY GMBH WAS INVESTIGATED THE PRODUCTS IN THE COMPLAINT LABORATORY. NO FAULTS WERE FOUND IN THE VISUAL INSPECTION OF TWO COMPLAINT SAMPLES. ALSO IN THE LEAK TEST ACCORDING TO LV 201 AND IN THE SIMULATED PRIMING PROCESS WITH WATER, NO DEFICIENCIES WERE FOUND. THE DEFICIENCIES CLAIMED BY THE CUSTOMER COULD NOT BE OBSERVED IN OUR INVESTIGATIONS AND THEREFORE NOT CONFIRMED. THE PROBLEM IS NOT REPRODUCIBLE. SAP TREND SEARCH WAS PERFORMED (COMPONENT QUADROX, FAILURE CODE 0311/1016 AIR IN THE SYSTEM) WHICH CAME TO FOLLOWING RESULTS: 7 ADDITIONAL COMPLAINTS WERE RECORDED WHICH APPEARS REPORTED ISSUES ARE THE SAME SINCE THE LAST 12 MONTHS. BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED: 0,12%, WHICH IS BELOW 1%. DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. DEVICE HISTORY RECORDS WERE REVIEWED. THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NON-CONFORMANCE OF THE PRODUCT IN QUESTION. THE REPORTED FAILURE DID NOT CONTRIBUTE TO DEATH OR SERIOUS INJURY. IN ADDITION IT CANNOT BE CONCLUDED AT THIS TIME THAT THIS IS SYSTEMIC ERROR. NO CORRECTIVE ACTION IS NEEDED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION YET. MAQUET CARDIOPULMONARY GMBH WILL SUBMIT A SUPPLEMENTAL MEDWATCH ON RECEIPT OF FURTHER INFORMATION. THE CASE WAS REPORTED TO THE MINISTRY OF HEALTH(MOH) ON (B)(6) 2018. (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    Description of Event or Problem · 0

    REF.: #(B)(4). , CUSTOMER REF(B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: "MORE LEAKAGE OF AIR WAS SEEN DURING PRIMING AT THE JUNCTION OF THE ARTERIAL FILTER TO MEMBRANE OF THE OXYGENATORS". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804694 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 71000 92226369

    Patients

    Seq Age Sex Outcome Treatment
    1