BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMLUNG OXYGENATOR

    MDR report key: 13235253 · Received January 12, 2022

    Report

    Report Number
    2531527-2022-00004
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    December 14, 2021
    Report Date
    January 12, 2022
    Manufacturer
    CARDIACASSIST INC.
    Product Code
    DTZ
    PMA / PMN Number
    K153295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARDIAC ASSIST INC. MANUFACTURES THE TANDEMLUNG OXYGENATOR. 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: OXYGENATOR WAS NOT AVAILABLE FOR RETURN SINCE IT WAS DISPOSED OFF. NO SERIAL NUMBER WAS PROVIDED THUS DHR REVIEW COULD NOT BE PERFORMED. ADDITIONAL INFORMATION REGARDING COAGULATION THERAPY AND ACT DURING SUPPORT WERE REQUESTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY CUSTOMER. THE DECREASE IN OXYGEN PERFOMANCE MAY HAVE BEEN DUE TO ACCUMULATION OF BIOLOGICAL DEPOSITS WITHIN THE OXYGENATOR LEADING TO A REDUCTION OF FLOW THROUGH THE DEVICE AND CONSEQUENTLY TO A DECREASE IN GAS EXCHANGE. HOWEVER, THIS COULD NOT BE CONFIRMED AND INFORMATION CURRENTLY AVAILABLE IS NOT SUFFICIENT TO DETERMINE THE ROOT CAUSE OF THE EVENT. BASED ON THE CURRENT LEVEL OF INFORMATION, IT CANNOT BE RULED OUT THAT THE REPORTED ISSUE IS NOT DEVICE RELATED AND IS ASSOCIATED TO PATIENT CONDITIONS.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED REPORT THAT DURING SUPPORT WITH A TANDEMLUNG OXYGENATOR AN ACUTE DESATURATION WITH ABG PO2 40 AND POST OXYGENATOR PO2 50 WAS NOTICED AND OXYGENATOR HAD TO BE EXCHANGED IMMEDIATELY. OXYGENATION IMPROVED AFTER DEVICE REPLACEMENT. THE OXYGENATOR WAS DISPOSED OF BY PROVIDER.T HE PATIENT REMAINS STABLE IN THE ICU.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888227 TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ CARDIACASSIST INC. 5160-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R