BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 13515316 · Received February 11, 2022

    Report

    Report Number
    9611109-2022-00061
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    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
    IT
    Reporter Occupation
    OTHER

    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). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE DEVICE WAS CLEANED AS PER THE INSTRUCTION FOR USE AND THAT IT WAS PLACED OUTSIDE THE OPERATING THEATRE DURING USE. CAUSE COULD NOT BE ESTABLISHED

    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). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE DEVICE WAS CLEANED AS PER THE INSTRUCTION FOR USE AND THAT IT WAS PLACED OUTSIDE THE OPERATING THEATRE DURING USE. CAUSE COULD NOT BE ESTABLISHED

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT, THE LABORATORY RESULTS SHOW CONTAMINATION WITH TO MNT CHIMAERA. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT, THE LABORATORY RESULTS SHOW CONTAMINATION WITH TO MNT CHIMAERA. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112219 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown