BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 13169468 · Received January 5, 2022

    Report

    Report Number
    9611109-2022-00008
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    September 29, 2021
    Report Date
    March 4, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 (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). 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

    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 (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). 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

    THROUGH PREVIOUS FOLLOW-UP COMMUNICATION FROM THE SAME HOSPITAL AND FOR THE SAME UNIT, LIVANOVA LEARNED THAT THE DEVICE WAS CLEANED REGULARLY PER THE INSTRUCTION FOR USE AND THAT IT WAS PLACED INSIDE THE OPERATING THEATER DURING USE WITH THE FAN DIRECTED AWAY FROM THE PATIENT AND AT AN ESTIMATED DISTANCE OF 3-4 METERS FROM THE SURGERY FIELD. NO ADDITIONAL INFORMATION IS AVAILABLE ABOUT THIS SPECIFIC CASE AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED A REPORT OF HEATER COOLER 3T CONTAMINATED WITH NTM CHIMAERA.NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED A REPORT OF HEATER COOLER 3T CONTAMINATED WITH NTM CHIMAERA.NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436338 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown