BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17341359 · Received July 18, 2023

    Report

    Report Number
    9611109-2023-00334
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    August 16, 2012
    Report Date
    February 29, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. G.5. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). H.9. LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THROUGH THE ANALYSIS OF THE INFORMATION RECEIVED, LIVANOVA LEARNED THAT HEATER COOLER SYSTEM DEVICES USED IN MARCH 2007 AT THIS HOSPITAL WERE THE FOLLOWINGS SERIAL NUMBERS: (B)(6), MODEL 16-02-80. THEY WERE DECOMMISSIONED FROM USE AND HAVE BEEN IN STORAGE FOR FOUR YEARS. ANOTHER HEATER COOLER DEVICE (MODEL: 16-02-80, SERIAL NUMBER: (B)(6) ) PRESENT AT HOSPITAL WAS INSTEAD SHIPPED BY THE CUSTOMER TO LIVANOVA DEUTSCHLAND FOR VACUUM & SEALING UPGRADE AND RETURNED AT THE BEGINNING OF SEPTEMBER 2019. BASED ON THE CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW UP COMMUNICATION, LIVANOVA LEARNED THAT POSSIBLE INVOLVED DEVICE SERIAL NUMBERS COULD BE THE FOLLOWING: (B)(6) OR (B)(6) (MODEL: 16-02-80). NO OTHER INFORMATION HAS BEEN MADE AVAILABLE FROM THE CUSTOMER. DEVICE HISTORY RECORDS (DHRS) REVIEW OF POSSIBLE INVOLVED DEVICE SERIAL NUMBERS HAS BEEN COMPLETED AND DID NOT IDENTIFY ANY DEVIATION OR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE. NO DEVICE, BETWEEN THE ONES POSSIBLE INVOLVED AND IN USE AT THE HOSPITAL AT THE TIME OF SURGERY (2012), WAS UPGRADED WITH VACUUM AND SEALING KIT. NO FURTHER INVESTIGATION IS POSSIBLE. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND A DIRECT RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT AND THE DEVICE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    THE EVENT WAS IDENTIFIED THROUGH A RETROSPECTIVE REVIEW OF PRODUCT LIABILITY LAWSUITS. THROUGH THIS REVIEW, WE HAVE IDENTIFIED A FEW EVENTS WHERE THE PLAINTIFF HAD FILED A SUIT AGAINST THE COMPANY, AND IT WAS HANDLED BY OUR LEGAL DEPARTMENT, BUT THE UNDERLYING PRODUCT INFORMATION HAD NOT BEEN FORWARDED TO THE COMPLAINT HANDLING UNIT. LIVANOVA OPENED A CAPA TO IDENTIFY ANY POSSIBLE LAWSUITS THAT MIGHT REQUIRE COMPLAINT REPORTING AND TO RETROSPECTIVELY SUBMIT THOSE EVENTS THAT WERE NOT PREVIOUSLY SUBMITTED AND TO PREVENT FUTURE SIMILAR ISSUES FROM OCCURRING. COMPLAINANT ALLEGES THROUGH THEIR COUNSEL THAT FOLLOWING AN AORTIC VALVE REPLACEMENT SURGERY DATED (B)(6) 2012, HE WAS FOUND TO BE INFECTED BY MYCOBACTERIUM CHIMAERA (IN AND/OR AROUND AORTIC VALVE BIOPROSTHESIS) ON (B)(6) 2016. HEATER-COOLER 3T WAS USED IN THIS SURGERY. DUE TO MYCOBACTERIUM CHIMAERA INFECTION HE HAS SUFFERED SERIOUS LOSS AND INJURY, INCLUDING REQUIRING THE INSERTION OF A MECHANICAL AORTIC VALVE REPLACEMENT INSTEAD OF THE BIOPROSTHESIS ONE, SUCH AS: DEGENERATIVE DISEASE OF WRISTS, HEARING LOSS AND TINNITUS, FATIGUE AND TIREDNESS, JOINT PAIN, LOW MOOD, ERECTILE DYSFUNCTION, POLYDIPSIA AND POLYURIA, INABILITY TO CONTINUE WORKING; WEEKLY BLOOD TESTS AND IT WILL REQUIRE LIFELONG ANTICOAGULATION TREATMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169093 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other