BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17376683 · Received July 24, 2023

    Report

    Report Number
    9611109-2023-00346
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    November 3, 2014
    Report Date
    October 23, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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) ITALY. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICES CURRENTLY IN USE AT THE HOSPITAL ARE THE FOLLOWING: 16S11815, 16S11814, 16S19142, 16S30310, 16S18818, 16S18318,16S17736. FIVE DEVICES MANUFACTURED AFTER THE SURGERY IN (B)(6) 2014 CAN BE EXCLUDED FROM THE ONES IN USE SINCE THEN. THE POSSIBLY INVOLVED DEVICES ARE THE FOLLOWING: 16S11815, 16S11814 (BOTH MANUFACTURED ON 16.09.2009). A SERVICE HISTORY CHECK DOCUMENTED UNDER # (B)(4) HAS BEEN PERFORMED FOR THESE DEVICES AND DID NOT IDENTIFY ANY DEVIATIONS RELEVANT TO THE REPORTED EVENT IN (B)(6) 2014. A REVIEW OF THE DHR ((B)(4) , (B)(4) DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AS PER FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, BETWEEN (B)(6) 2014 AND (B)(6) 2015 THE CUSTOMER DID NOT TRACK THE SERIAL NUMBER USED FOR THE SURGERY. HOWEVER, IT WAS POSSIBLE TO TRACE THE SERIAL NUMBERS OF THE MACHINES USED AT THE CUSTOMER FACILITY AT THE TIME OF THE EVENT WHICH ARE (B)(6) AND (B)(6) AS PER ABOVE. IN ADDITION, THE CUSTOMER COMMUNICATED THAT: - THE DEVICE WAS CLEANED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE VALID AT THE TIME OF THE INTERVENTION. - THE FAN OF THE DEVICE WAS ORIENTED AWAY FROM THE SURGICAL FIELD. - SINGLE-PATIENT HEATED MATTRESSES WERE SOMETIMES USED IN THE PAST AND REPORTEDLY THE INSTRUCTIONS FOR USE WERE ALWAYS FOLLOWED. - MICROBIAL SAMPLING AND TESTING WERE CONDUCTED. RESULTS HAVE NOT BEEN SHARED WITH LIVANOVA AND THERE IS NO EVIDENCE THAT THE DEVICES WERE FOUND TO BE CONTAMINATED. - THE WASHING AND DISINFECTION MECHANISMS HAVE ALWAYS OCCURRED IN ACCORDANCE WITH THE MANUFACTURER'S INSTRUCTIONS, AS DOCUMENTED BY THE REGISTERS OF THE OPERATING DEPARTMENT. THE PROTOCOLS WERE MODIFIED IN (B)(6) 2015, IN FULL APPLICATION OF THE CONTENTS OF FIELD SAFETY NOTICE OF JUNE 2015. THEY WERE THEN CONFIRMED FOLLOWING THE SECOND FIELD SAFETY NOTICE OF NOVEMBER 2016. - UNTIL (B)(6) 2016, THE WATER DESTINED FOR THE HEATER COOLERS WAS TREATED WITH A DISINFECTANT INDICATED BY THE MANUFACTURER; SINCE (B)(6) 2016 A PAL FILTER WAS USED ON THE TERMINAL DEDICATED TO THE HEATER COOLERS FOR FILLING DEVICE TANKS AND REPLACED ACCORDING TO THE PERIODICITY INDICATED BY THE MANUFACTURER. - THE SAMPLING AND TESTING OF THE WATER SOURCES WERE NOT CARRIED OUT AT THE CUSTOMER SITE BECAUSE THEY WERE NOT REQUIRED BY THE REGULATIONS OF THE TIME. - THE PATIENTS DID NOT DIE AT THE CUSTOMER FACILITY THEREFORE THE CUSTOMER DOES NOT HAVE DEATH CERTIFICATE AND THE FACILITY IS NOT AWARE OF THE PRIMARY AND SECONDARY CAUSE OF DEATH. - FOLLOWING THE DISCOVERY OF INFECTIONS THE DEVICES WERE NO LONGER USED, TAKEN OUT OF OPERATION AND PUT UNDER SEAL. REPORTEDLY THE CUSTOMER OBSERVED THE NATIONAL SURVEY ON THE INCIDENCE OF MYCOBACTERIUM CHIMAERA PROSTHETIC INFECTIONS ASSOCIATED WITH THE USE OF HEAT COOLERS IN CARDIAC SURGERY, THE FIELD SAFETY NOTICE ISSUED BY LIVANOVA AND ECDC GUIDELINES. SINCE (B)(6) 2009 (WHEN BOTH ABOVE-MENTIONED DEVICES WERE INSTALLED) THE FOLLOWING MEASURES HAVE BEEN TAKEN: IMMEDIATE ADOPTION OF THE MAINTENANCE AND DISINFECTION PROCEDURE, IN COMPLIANCE WITH THE MANUFACTURER'S INSTRUCTIONS. FOLLOWING THE FIRST NOTICE, SALUS HOSPITAL PROCEEDED TO APPLY THE NEW DISINFECTION METHODS, CONTAINED IN THE NOTICE ITSELF AND IN THE NEW EDITION OF THE INSTRUCTION FOR USE IN (B)(6) 2015, THE CUSTOMER INCREASED THE FREQUENCY OF DISINFECTIONS FROM BIWEEKLY TO WEEKLY (AS INDICATED BY LIVANOVA); POSITIONED THE MACHINE AS FAR AS POSSIBLE FROM THE OPERATING FIELD AND NOT ORIENTED DIRECTLY TOWARDS THE OPERATING FIELD AND APPLIED DAILY REPLACEMENT OF THE WATER IN THE DEVICE TANKS. A COMPLAINTS DATABASE REVIEW REVEALED THAT NO DEVICE CONTAMINATION COMPLAINTS WERE RECEIVED UNTIL THE FIRST SUBMITTED FROM THIS CLINIC IN (B)(6) 2018. MOREOVER, NO EVENTS OF DEVICE CONTAMINATION WERE SUBMITTED FOR THE ABOVE-MENTIONED SERIAL NUMBERS AND BASED ON THE COLLECTED INFORMATION THERE IS NO EVIDENCE THAT THE DEVICES WERE FOUND TO BE CONTAMINATED. DESPITE A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED ADVERSE EVENT CANNOT BE EXCLUDED, NO DEFINITIVE CONCLUSION COULD BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THE HOSPITAL WHERE THE SURGERY TOOK PLACE. HOSPITAL NAME AND ADDRESS HAVE BEEN ADDED TO THE DEDICATED E SECTION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    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 A MYCOBACTERIUM CHIMAERA INFECTION. BASED ON CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794396 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other