BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPINE 20FRENCH FEMORAL VENOUS CANNULA

    MDR report key: 17182273 · Received June 21, 2023

    Report

    Report Number
    MW5118502
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    June 6, 2023
    Report Date
    June 16, 2023
    Manufacturer
    SURGE CARDIOVASCULAR/MED MICHIGAN HOLDINGS LLC
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CANNULATED WITH ALPINE 20FRENCH FEMORAL VENOUS CANNULA FOR USE IN ECMO. STAFF NOTED DECREASED FLOWS WHILE ON ECMO. PROVIDER DE-CANNULATED PATIENT APPROXIMATELY 3.5HRS AFTER INITIAL CANNULATION AND REMOVED 20FRENCH CANNULA FROM LEFT FEMORAL VEIN NOTING IT TO BE FRACTURED IN HALF. PATIENT WAS RE-CANNULATED WITHOUT ISSUE. ON (B)(6) 2023, PATIENT WAS AGAIN DE-CANNULATED DUE TO DECREASED FLOWS. THIS TIME A 24FRENCH CANNULA WAS REMOVED FROM THE RIGHT FEMORAL VEIN AND NOTED TO BE FRACTURED IN HALF. NO HARM TO PATIENT EITHER TIME. REFERENCE REPORT: MW5118501.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866265 ALPINE 20FRENCH FEMORAL VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SURGE CARDIOVASCULAR/MED MICHIGAN HOLDINGS LLC 06691-041823

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Hospitalization| R