BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMLUNG OXYGENATOR

    MDR report key: 10683998 · Received October 15, 2020

    Report

    Report Number
    2531527-2020-00033
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    June 5, 2020
    Report Date
    October 13, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTZ
    PMA / PMN Number
    K153295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: BASED ON THE AVAILABLE INFORMATION, THE OXYGENATOR WORKED ACCORDING TO THE SPECIFICATION FOR 8 DAYS. IT CANNOT BE RULED OUT THAT THE PROLONGED USE OF THE OXYGENATOR WITH THE CONTRIBUTION OF THE PRE-EXISTING PATIENT CONDITION MAY HAVE LED TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. CARDIAC ASSIST INC. MANUFACTURES THE TANDEMLUNG OXYGENATOR. THE INCIDENT OCCURRED IN UNITED STATES. 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 (B)(4) RECEIVED A REPORT THAT A (B)(6) YEAR OLD MALE PATIENT WAS PLACED ON SUPPORT ON (B)(6) 2020 WITH THE TANDEMHEART PUMP, TANDEMHEART TRANSSEPTAL CANNULA, TANDEMLUNG OXYGENATOR, AND ANOTHER MANUFACTURER¿S VENOUS CANNULA. THE TANDEMLUNG OXYGENATOR WAS CHANGED-OUT DUE TO WORSENING POST-OXYGENATOR SATURATIONS. REPORTEDLY, THERE WAS NO CLOT OR HEMOLYSIS DOCUMENTED. THE TANDEMHEART DEVICE WAS WEANED AND REMOVED ON (B)(6) 2020 WITHOUT FURTHER NEED FOR SUPPORT. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020 TO AN EXTENDED CARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151836 TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ LIVANOVA DEUTSCHLAND 5160-0000

    Patients

    Seq Age Sex Outcome Treatment
    1