BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER COOLER 3T

    MDR report key: 19710652 · Received July 10, 2024

    Report

    Report Number
    9611109-2024-00309
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    March 16, 2015
    Report Date
    July 10, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1-A.5. PATIENT INFORMATION WAS NOT PROVIDED D.4. THE CATALOGUE AND SERIAL NUMBER ARE UNKNOWN. THEREFORE UDI IS UNKNOWN. 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: K220635). 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. 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 COULD NOT BE PERFORMED SINCE POSSIBLE SERIAL NUMBERS INVOLVED COULD NOT BE PROVIDED. 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

    LEGAL LAWSUIT HAS BEEN ISSUED AND NO OTHER INFORMATION HAS BEEN MADE AVAILABLE OTHER THAN THAT REPORTED IN THE COMPLAINT FILE AND ATTACHED IN THE ATTACHMENTS SECTION. 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. INVOLVED DEVICE SERIAL NUMBER REMAINED UNKNOWN BUT WAS NOT EQUIPPED WITH VACUUM AND SEALING KIT SINCE UPGRADE ACTIVITY STARTED IN 2017. 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. NO OTHER ACTION IS DEEMED NECESSARY. THE RISK IS IN THE ACCEPTABLE REGION. LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, ON (B)(6) 2015, THE PATIENT UNDERWENT A SURGICAL PROCEDURE INVOLVING MINIMALLY INVASIVE MITRAL VALVE REPAIR. ON (B)(6) 2016, CULTURES PERFORMED ON SAMPLES TAKEN, REVEALED THE PRESENCE OF A DISSEMINATED M. CHIMAERA INFECTION. THE PATIENT UNDERWENT REGULAR MEDICAL FOLLOW-UP AND NUMEROUS TESTS, EXAMINATIONS, AND TREATMENTS, INCLUDING SURGERIES. PATIENT¿S CURRENT STATUS IS UNKNOWN.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351823 HEATER COOLER 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other