BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMLUNG OXYGENATOR

    MDR report key: 10051759 · Received May 13, 2020

    Report

    Report Number
    2531527-2020-00016
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    August 10, 2018
    Report Date
    April 13, 2020
    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

    H.10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE ISSUE WAS RESOLVED DURING THE PROCEDURE BY STOPPING THE PUMP FOR ONE MINUTE AND EXCHANGING THE OXYGENATOR. THE SUPPORT WAS THUS STARTED AGAIN. CLOTTING IS A MULTIFACTORIAL EVENT THAT MAY BE RELATED TO INSUFFICIENT ANTICOAGULATION, EXTENDED PERIODS OF LOW FLOW AND PATIENT COAGULOPATHIES. BASED ON THE AVAILABLE INFORMATION, THE EXACT CAUSE OF THE THROMBUS FORMATION IS THIS CASE CANNOT BE DETERMINED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LOT NUMBER IS UNKNOWN. IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AVAILABLE. CARDIAC ASSIST INC. MANUFACTURES THE TUNDEMLUNG OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). 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 A REPORT THAT DURING A SUPPORT, AFTER TANDEMHEART INSERTION, A THROMBUS FORMATION WAS OBSERVED IN THE CIRCUIT AT THE PROXIMAL SIDE OF THE TUNDEMLUNG OXYGENATOR. THE TANDEMHEART COMPONENT AND THE OXYGENATOR WERE EXCHANGED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514658 TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ CARDIACASSIST INC. 5160-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention