BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 7818782 · Received August 27, 2018

    Report

    Report Number
    8010762-2018-00248
    Event Type
    Death
    Date Received
    August 27, 2018
    Date of Event
    August 8, 2018
    Report Date
    December 19, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4). THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION IN THE LABORATORY OF MANUFACTURER AS THE INDIAN CUSTOMS DEPARTMENT HAS NOT ALLOWED TO SHIP BACK THE DEFECTIVE DEVICE. SAP TREND SEARCH WAS PERFORMED (PRODUCT GROUP 31000&56000 (PRODUCTS WHICH OXYGENATOR IS A COMPONENT OF), FAILURE CODE 0306 OXYGENATION-BAD PERFORMANCE) WHICH CAME TO FOLLOWING RESULTS: 11 ADDITIONAL COMPLAINTS WERE RECORDED WHICH APPEARS REPORTED ISSUES ARE SAME SINCE THE LAST 12 MONTHS. HOWEVER THESE COMPLAINTS ARE IN STATUS 'NOT CONFIRMED'. BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED: (B)(4), WHICH IS BELOW THAN (B)(4). DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. THE AVAILABLE INFORMATION HAS BEEN SHARED INTERNALLY WITH GETINGE THERAPY APPLICATION MANAGER. IT WAS STATED THAT: "WITH THE INFORMATION AVAILABLE THERE IS NO CONCLUSION POSSIBLE THAT THE DEVICE WAS DEFECTIVE, NOR THAT IT WAS SOUND." AND "WITH THE UNDERLYING INFORMATION NO PROPER CONCLUSIONS CAN BE DRAWN TO WHAT EXTENT THE DEVICE DID CONTRIBUTE TO THE DEAD OF THE PATIENT". THE CUSTOMER DID NOT REPLY ALL QUESTIONS WHICH WERE ASKED BY THERAPY APPLICATION MANAGER. THE INFORMATION OBTAINED SO FAR IS NOT ENOUGH TO CONFIRM THAT DEVICE CONTRIBUTED TO THE DEATH OF A PATIENT. ON THE OTHER HAND AT THIS TIME NO SIMILAR COMPLAINT INVESTIGATED WAS FOUND WHICH COULD LED TO THE CONFIRMATION OF THE FAILURE AND / OR A PRODUCT RELATED MALFUNCTION. THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING&APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: "WHILE IN USE GRADUALLY PRE-MEMBRANE PRESSURE INCREASED AND PO2 LEVEL DROPPED. BLOOD BECAME DARK EVEN WITH 100% FIO2 AND THEN WE CHANGED TO DIRECT O2 SUPPLY FROM A CYLINDER AT 6-7/HS/MIN, STILL WE WERE UNABLE TO OBTAIN PAO2 AND SATURATIONS. HENCE OXYGENATOR CHANGED THE SURGERY COMPLETED. PATIENT SUBSEQUENTLY DIED IN THE ICU." (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660784 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 70000 92235776

    Patients

    Seq Age Sex Outcome Treatment
    1 Death