BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CARDIOVASCULAR

    MDR report key: 16630802 · Received March 28, 2023

    Report

    Report Number
    3017540705-2022-00001
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    February 23, 2022
    Report Date
    March 14, 2022
    Manufacturer
    MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR
    Product Code
    DWF
    PMA / PMN Number
    K964200
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OCCLUSION WITHIN TUBING BOND JOINT OF THE MULTI-PERFUSION ADAPTER PREVENTING FLOW DURING AORTIC VALVE REPLACEMENT (AVR) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420774 TERUMO CARDIOVASCULAR MULTI PERFUSION ADAPTER DWF MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR PERFUSION SET 03418-121319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention