BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10903488 · Received November 25, 2020

    Report

    Report Number
    9611109-2020-00658
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    December 18, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE DEVICE WAS PLACED INSIDE THE OPERATING THEATRE DURING USE WITH THE FAN DIRECTED OPPOSITE TO THE PATIENT AT AN ESTIMATED DISTANCE OF TWO (2) METERS FROM THE SURGERY FIELD. IN ADDITION, LIVANOVA LEARNED THAT THE DEVICE IS CLEANED REGULARLY IN TERMS OF TIMELINES AND THAT THE HOSPITAL USES A RECIPE SIMILAR TO CLOROX DISINFECTANT. THIS IS NOT IN ACCORDANCE WITH THE LIST OF APPROVED DISINFECTANTS PRESCRIBED WITHIN THE IFU. THIS MAY HAVE LED/CONTRIBUTED TO THE REPORTED CONTAMINATION.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. 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 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 ROME, ITALY. 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 · 1

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHIMAERA. THE LABORATORY REPORT CONFIRMING THE REPORTED CONTAMINATION HAS BEEN PROVIDED TO LIVANOVA AND IT REFERS TO PRE-DISINFECTION CYCLE SAMPLES. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369175 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1