BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMLUNG OXYGENATOR

    MDR report key: 12428296 · Received September 6, 2021

    Report

    Report Number
    2531527-2021-00034
    Event Type
    Injury
    Date Received
    September 6, 2021
    Date of Event
    August 6, 2021
    Report Date
    September 6, 2021
    Manufacturer
    CARDIACASSIST INC.
    Product Code
    DTZ
    PMA / PMN Number
    K153295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: A MEDICAL ASSESSMENT HAS BEEN CONDUCTED ON THE REPORTED EVENT. THE PROTOCOL FOR DEVICE EXCHANGE LED TO PATIENT VOLUME REDUCTION WITH CONSEQUENT MEDICAL INTERVENTION. THE EVENT IS THEREFORE RELATED TO THE PROCEDURE FOR DEVICE EXCHANGE AND NOT TO PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 0

    H.10: THE EVENT OCCURRED AFTER 11 DAYS OF SUPPORT ON COVID-19 PATIENT. COVID-19 DISEASE CAN CONTRIBUTE/LEAD TO CLOTTING FORMATION DUE TO A HIGHER INCIDENCE OF COAGULOPATHY AND THROMBOSIS. THIS FACTORS MAY AFFECT OXYGENATOR PERFORMANCE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY OXYGENATOR MALFUNCTION. THEREFORE, THE REPORTED EVENT IS MOST LIKELY DUE TO SEVERE PATIENT CONDITION WITH THE CONTRIBUTION OF PROLONGED DEVICE USAGE. IN CONCLUSION, THIS CASE IS A NON DEVICE-RELATED EVENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. CARDIACASSIST 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.

    Description of Event or Problem · 1

    LIVANOVA RECEIVED REPORT THAT TANDEMLUNG OXYGENATOR (ORIGINALLY PLACED ON (B)(6) 2021) WAS CHANGED OUT DUE TO CO2 REMOVAL DECREASE. AFTER REPLACEMENT, THE PATIENT DEVELOPED A SIRS RESPONSE WITH ANEMIA DUE TO VOLUME LOSS WITH OXYGENATOR EXCHANGE. TRANSFUSION WAS GIVEN AND BP WAS INCREASED WITH NEO. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326026 TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ CARDIACASSIST INC. 5160-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other