BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3T HEATER COOLER

    MDR report key: 17403947 · Received July 27, 2023

    Report

    Report Number
    9611109-2023-00360
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    March 13, 2015
    Report Date
    October 19, 2023
    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
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A COMPLAINTS DATABASE REVIEW, LIVANOVA DETERMINED THAT THE PRESENT MEDWATCH WAS ALREADY COMMUNICATED AS MEDWATCH 9611109-2016-00669. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED WITH RESPECT TO THE INFORMATION ALREADY REPORTED IN THE PREVIOUS REPORT.

    Additional Manufacturer Narrative · 0

    A.2-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 CATALOGUE IS UNKNOWN. HOWEVER, THE COMPLAINED HEATER COOLER IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). 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. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN UNITES STATES. LIVANOVA INITIATED AN INVESTIGATION. 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

    SEE INTIAL 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 AS A RESULT OF A SURGERY. BASED ON CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133472 3T HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown