BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 13514524 · Received February 11, 2022

    Report

    Report Number
    9611109-2022-00059
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    November 24, 2021
    Report Date
    February 11, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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, 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). A COMPLAINTS DATABASE REVIEW REVEALED NO PREVIOUS DEVICE CONTAMINATION COMPLAINTS SUBMITTED BY THIS HOSPITAL. 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). A COMPLAINTS DATABASE REVIEW REVEALED NO PREVIOUS DEVICE CONTAMINATION COMPLAINTS SUBMITTED BY THIS HOSPITAL. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT IT WAS STATED THE FOLLOWING: "A COMPLAINTS DATABASE REVIEW REVEALED NO PREVIOUS DEVICE CONTAMINATION COMPLAINTS SUBMITTED BY THIS HOSPITAL." PLEASE CONSIDER THIS STATEMENT INCORRECT DUE TO COPY AND PASTE ERROR. PLEASE CONSIDER VALID THE BELOW: "A COMPLAINTS DATABASE REVIEW REVEALED PREVIOUS DEVICE CONTAMINATION COMPLAINTS SUBMITTED BY THIS HOSPITAL." H.10: A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THROUGH FOLLOW-UP COMMUNICATION UNDER THE PREVIOUS COMPLAINT, LIVANOVA LEARNED THAT THE DEVICE WAS CLEANED REGULARLY ACCORDING TO THE INSTRUCTION FOR USE AND THAT IT WAS MONITORED WEEKLY FOR HYDROGEN PEROXIDE (H2O2) CONCENTRATION DURING WATER CHANGE. AS PER DEVICE INSTRUCTION FOR USE, H2O2 IS REQUIRED TO BE CHECKED DAILY AND A DEVIATION FROM IFU MAY HAVE LED/CONTRIBUTED TO THE REPORTED CONTAMINATION. THE DEVICE WILL BE SENT TO THE MANUFACTURER SITE FOR DEEP DISINFECTION IN ORDER TO SOLVE THE REPORTED ISSUE.

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT, THE LABORATORY RESULTS SHOW CONTAMINATION BY MYCOBACTERIA AVIUM CHIMAERA, DURING PERIODIC MONTHLY CHECK. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT, THE LABORATORY RESULTS SHOW CONTAMINATION BY MYCOBACTERIA AVIUM CHIMAERA, DURING PERIODIC MONTHLY CHECK. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76354 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown