BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER COOLER SYSTEM

    MDR report key: 21604249 · Received March 14, 2025

    Report

    Report Number
    9611109-2025-00105
    Event Type
    Death
    Date Received
    March 14, 2025
    Date of Event
    February 20, 2015
    Report Date
    March 14, 2025
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION NOT AVAILABLE. D.4 UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS NOT AVAILABLE FOR THIS PRODUCT AS IT IS A CLASS II MEDICAL DEVICE MANUFACTURED BEFORE SEPTEMBER 24, 2016 WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. 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: K220635). 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. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. DHR REVIEW OF INVOLVED DEVICE SERIAL NUMBER HAS BEEN COMPLETED AND DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. ANALYSIS OF COMPLAINTS REPORTED BY SAME HOSPITAL DIDN'T IDENTIFY ANY EVIDENCE OF CLINICAL PRACTICES DEVIATIONS. THE INVOLVED DEVICE IN USE AT THE HOSPITAL AT THE TIME OF SURGERY ((B)(6) 2015) WAS NOT YET EQUIPPED WITH VACUUM AND SEALING KIT AND SUBSEQUENTLY SCRAPPED IN (B)(6) 2019. BASED ON ALL KNOWN FACTS, SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND THE LIVANOVA DEVICE INVOLVEMENT AS WELL. LIVANOVA ALREADY IMPLEMENTED A STRATEGY TO DECREASE THE PROBABILITY OF BACTERIA GROW IN THE HC DEVICE BY APPLYING MULTIPLE MEASURES IMPLEMENTED OVER THE PAST FEW YEARS THROUGH DEDICATED CAPA AND FIELD ACTION. LIVANOVA BECAME AWARE OF THESE CASES THROUGH LEGAL ACTIONS. ACCORDING TO THE LIVANOVA LEGAL COUNSEL, THESE ARE THE ONLY AVAILABLE DETAILS AT THE MOMENT, AND WE DO NOT EXPECT TO RECEIVE ADDITIONAL INFORMATION IN THE NEAR FUTURE. THEREFORE, THE COMPANY WILL PROCEED WITH CLOSING THE CASE. HOWEVER, IF NEW INFORMATION BECOMES AVAILABLE THROUGH THE DISCOVERY PROCESS, THE COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY. LIVANOVA HAS A PERIODIC PROCESS FOR UPDATING LEGAL CASES IN COLLABORATION WITH ITS LEGAL COUNSEL, ENSURING THAT ANY NEW INFORMATION WILL BE COLLECTED AND MANAGED EVEN AFTER THE CASE IS CLOSED. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS USED DURING A MITRAL VALVE REPAIR AND TRICUSPID VALVE ANNULOPLASTY SURGERY PERFORMED ON (B)(6) 2015. PATIENT, SUBSEQUENTLY DEVELOPED SYMPTOMS INCLUDING NIGHT SWEATS AND FEVERS. IN 2017, PATIENT RECEIVED CORRESPONDENCE FROM LGI ADVISING RISK OF DEVELOPING M. CHIMAERA FOLLOWING SURGERY IN (B)(6) 2015. VARIOUS INVESTIGATIONS WERE PERFORMED AND IT WAS NOT UNTIL 2023 THAT M. CHIMAERA WAS IDENTIFIED FOLLOWING A SPINAL BIOPSY. IN (B)(6) 2023, PATIENT WAS ADMITTED TO (B)(6) HOSPITAL (IN (B)(6)), WHERE PATIENT WAS INFORMED OF THE NEED OF TREATMENT FOR M. CHIMAERA. TREATMENT WAS NOT SUCCESSFUL, AND PATIENT DIED ON (B)(B) 2024. IT HAS SINCE BEEN CONFIRMED BY (B)(6) HOSPITAL THAT THE HCU IN QUESTION WAS CONTAMINATED WITH M. CHIMAERA, AND IT WAS TAKEN OUT OF SERVICE IT SOME POINT IN 2015/2016. HOSPITAL NOTICE: JUNE 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031841 HEATER COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death