BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 13577618 · Received February 22, 2022

    Report

    Report Number
    9611109-2022-00073
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Report Date
    February 22, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901099
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. 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: K191402). LIVANOVA (B)(6) IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA (B)(6) 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, BUT 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

    H.10: THROUGH FOLLOW-UP COMMUNICATION UNDER PREVIOUS EVENTS FROM THIS SAME HOSPITAL, LIVANOVA LEARNED THAT THE DEVICE WAS CLEANED AND MAINTAINED 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 TWO (2) METERS FROM THE SURGERY FIELD. IN ORDER TO SOLVE THE REPORTED ISSUE, CUSTOMER REQUESTED DEEP DISINFECTION AT THE MANUFACTURER SITE. THE ROOT CAUSE OF THE REPORTED CONTAMINATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    LIVANOVA (B)(6) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHIMAERA AND SPHINGOMONAS PAUCIMOBILIS. THE LABORATORY REPORT CONFIRMING THE REPORTED CONTAMINATION HAS BEEN PROVIDED TO LIVANOVA. THE CUSTOMER REQUESTED DEEP DISINFECTION TO SOLVE THE REPORTED ISSUE. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHIMAERA AND SPHINGOMONAS PAUCIMOBILIS. THE LABORATORY REPORT CONFIRMING THE REPORTED CONTAMINATION HAS BEEN PROVIDED TO LIVANOVA. THE CUSTOMER REQUESTED DEEP DISINFECTION TO SOLVE THE REPORTED ISSUE. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685101 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown