BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10475679 · Received September 1, 2020

    Report

    Report Number
    9611109-2020-00496
    Event Type
    Injury
    Date Received
    September 1, 2020
    Report Date
    August 31, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINTS DATABASE ANALYSIS REVEALED PREVIOUS DEVICE CONTAMINATION COMPLAINTS SUBMITTED FROM THIS HOSPITAL AND NO PATIENT INJURY WAS NEVER REPORTED. THROUGH FOLLOW UP COMMUNICATION UNDER THESE PREVIOUS DEVICE CONTAMINATION CASES, LIVANOVA LEARNED THAT THE USERS WERE NOT CONSISTENT WITH THE INSTRUCTION FOR USE REGARDING MAINTENANCE AND CLEANING PROCEDURE. A TRAINING WAS CONDUCTED TO REINFORCE THE CLEANING PROCEDURE STEPS AND TO ENSURE ALL USERS TO BE CONSISTENT WITH THE CLEANING PROTOCOLS. BASED ON THE INFORMATION CURRENTLY AVAILABLE THERE IS NO CONFIRMED CORRELATION BETWEEN THE HEATER-COOLER AND THE REPORTED INFECTION. THE ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. 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). 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). THE SERIAL NUMBER OF THE DEVICE USED DURING THE SURGERY AS WELL AS THE DATE OF THE REPORTED PROCEDURE REMAIN UNKNOWN. LIVANOVA WILL ATTEMPT TO OBTAIN FURTHER INFORMATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THROUGH LITERATURE REVIEW LIVANOVA BECAME AWARE OF A PATIENT INFECTED WITH MYCOBACTERIUM CHIMAERA (MC) DETECTED IN ROUTINE POST THAW CULTURE OF A PULMONARY VALVE HOMOGRAFT, PRIOR TO IMPLANTATION IN A TEENAGE RECIPIENT . BEFORE CLINICAL RELEASE, THE HOMOGRAFT WAS PROCESSED UNDER ASEPTIC CONDITIONS AND ALL MICROBIOLOGICAL CULTURES WERE NEGATIVE. THE HOMOGRAFT WAS THAWED INSIDE THE CARDIAC OPERATING THEATER AND A POST THAW TISSUE CULTURE SAMPLE WAS TAKEN AS PER THE STANDARD OPERATING PROCEDURE. THIS POST THAW CULTURE SAMPLE FROM THE PULMONARY HOMOGRAFT GREW M. CHIMAERA. AN HEATER-COOLER WAS IN USE IN THE CARDIAC THEATER AT THE TIME OF THE THAWING OF THE HOMOGRAFT. AFTERWARDS, THE HEATER-COOLER USED IN THE IMPLANT SURGERY WAS FOUND TO HAVE BEEN CONTAMINATED WITH M. CHIMAERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939846 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other