BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6852331 · Received September 8, 2017

    Report

    Report Number
    9611109-2017-00698
    Event Type
    Death
    Date Received
    September 8, 2017
    Date of Event
    August 9, 2017
    Report Date
    May 28, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP COMMUNICATION LIVANOVA (B)(4) LEARNED THAT INVOLVED PATIENT PASSED AWAY ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    PMA 510(K): THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K052601). RECALL NUMBER. LIVANOVA (B)(4) IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). FROM PRIOR COMMUNICATION WITH THE CUSTOMER, LIVANOVA (B)(4) HAS IDENTIFIED THAT THREE OF THE HEATER-COOLER DEVICES IN USE AT THE FACILITY HAVE TESTED POSITIVE FOR MYCOBACTERIUM CHIMAERA (REFER TO 9611109-2017-00114, 9611109-2017-00115 AND 9611109-2017-00116). HOWEVER, IT IS UNKNOWN WHICH DEVICE WAS USED DURING THE PROCEDURE. THE CUSTOMER REPORTED THAT THE HEATER-COOLER DEVICES WERE PLACED INSIDE THE OPERATION THEATER DURING USE POSITIONED APPROXIMATELY 4 METERS FROM THE PATIENT FIELD WITH THE REAR END OF THE DEVICE DIRECTED AWAY FROM THE PATIENT. THROUGH FOLLOW-UP COMMUNICATION FOR PREVIOUS CASES, LIVANOVA (B)(4) LEARNED THAT THE FACILITY HAS FOLLOWED THE UPDATED CLEANING GUIDELINES ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR ALL THEIR UNITS SINCE JUNE 2014. IT WAS ALSO REPORTED THAT IN LATE 2015, THE FACILITY PERFORMED A PROLONGED AND INTENSE MINNCARE TREATMENT USING THE RECOMMENDED CONCENTRATION OF DISINFECTANT, THE RECOMMENDED TANK TEMPERATURES, AND INCREASED CONTACT TIME OF 60 TO 120 MINUTES INSTEAD OF 15 MINUTES. THROUGH ADDITIONAL FOLLOW-UP WITH THE CUSTOMER, LIVANOVA (B)(4) LEARNED THAT ALL THREE UNITS HAVE BEEN REPLACED AND THAT THE CUSTOMER DOES NOT WISH TO PROVIDE FURTHER INFORMATION REGARDING THE EVENT AT THIS TIME. A REVIEW OF THE DHRS FOR ALL POTENTIALLY INVOLVED DEVICES DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A PATIENT BECAME INFECTED MYCOBACTERIUM AFTER UNDERGOING AN AORTIC VALVE REPLACEMENT ON (B)(6) 2015. A HEATER-COOLER SYSTEM 3T WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631393 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| O