BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 7553092 · Received May 30, 2018

    Report

    Report Number
    8010762-2018-00191
    Event Type
    Death
    Date Received
    May 30, 2018
    Date of Event
    February 20, 2018
    Report Date
    August 29, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    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. IMPORTER- (B)(4). CONTACT PERSON- (B)(6). THE LOT NUMBER OF THE SET WAS REQUESTED AT LEAST THREE TIMES FROM THE SSU, BUT, THEY COULD NOT REACH THE EXACT LOT NUMBER OF THE CLAIMED SET. THEREFORE, DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ADDITIONALLY, THE SAMPLE WAS DISCARDED BY THE HOSPITAL. SAP TREND SEARCH WAS PERFORMED (MATERIAL (B)(4), SIMILAR FAILURE) WHICH CAME TO FOLLOWING RESULTS: NO ADDITIONAL COMPLAINT WAS RECORDED. BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED: 0%, WHICH IS BELOW 1%. DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. AS IT IS NOT POSSIBLE TO INVESTIGATE FURTHER IN THIS CASE, IT IS NOT POSSIBLE TO DETERMINE A CLEAR ROOT CAUSE FOR THE FAILURE. BASED ON THE INSUFFICIENT INFORMATION REGARDING TO COMPLAINT, THE FAILURE COULD NOT BE CONFIRMED. THE DATA IS 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

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

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: "(B)(6) YEARS OLD MALE UNDERGOING CABG+VSR REPAIR ON (B)(6) 2018. WENT ON CPB AND FIRST PAO2 (31 MINUTES AFTER CPB ESTABLISHED)WAS 259. AFTER 161 MINUTE, PAO2 DROPPED TO 125 MMHG, FIO2 WAS INCREASED TO 0,8. AFTER ANOTHER 25 MINUTES, PAO2 FURTHER DROPPED TO 74 MMHG. OXYGEN SUPPLY SOURCE WAS IMMEDIATELY CHECKED AND EVALUATED AS PRE-CAUTION, BUT ARTERIAL BLOOD REMAINED DEOXYGENATED. OXYGENATOR HAD TO BE CHANGED WHILE PATIENT WAS FULLY REWARMED BUT STILL IN ASYSTOLE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395144 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 78000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death