BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGE CARDIOVASCULAR

    MDR report key: 17278086 · Received July 7, 2023

    Report

    Report Number
    3017540705-2023-00003
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 7, 2023
    Manufacturer
    MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR
    Product Code
    DWF
    PMA / PMN Number
    K081933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THE ALPINE FEMORAL VENOUS CANNULA 20FR HAD POOR DRAINAGE DURING ECMO PROCEDURE AND FRACTURED IN HALF DURING REMOVAL. NO HARM TO PATIENT. ECMO PROCEDURE IS NOT IN ACCORDANCE WITH THE INDICATIONS OF USE FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421342 SURGE CARDIOVASCULAR ALPINE FEMORAL VENOUS CANNULA DWF MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR FEM-V1020 06691-041823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R