BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DLP

    MDR report key: 23704542 · Received December 3, 2025

    Report

    Report Number
    23704542
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 16, 2025
    Report Date
    November 20, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    S [SITUATION]: PATIENT ON VA ECMO [VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION] WITH CENTRAL CANNULATION. ON [REDACTED DATE], LA [LEFT ATRIAL] VENT FLOW REDUCED. TEAM PLANNED FOR ELECTIVE CANNULA CHANGE. B [BACKGROUND]: [REDACTED]. PATIENT CAME OFF BYPASS WITH LAP [LEFT ARTERIAL PRESSURE] 25-35, NO EJECTION AND SEVERE LV [LEFT VENTRICLE] SYSTOLIC DEPRESSION; THEREFORE, PATIENT WAS CANNULATED ONTO CENTRAL VA-ECMO. A [ASSESSMENT]: DURING CANNULA CHANGE, CANNULA WAS FOUND TO BE DEFECTIVE, PATIENT DID NOT SUFFER ANY HARM FROM THE DEFECT. LA VENT FLOW DECREASED, TEAM HAD PLANNED TO TAKE PATIENT TO CATH LAB FOR ROUTINE CANNULATED CHANGE. WHEN CANNULA ASSESSED, NOTED 4 TEARS IN CANNULA. CARE TEAM HAVE REPORTED THIS TO MEDTRONIC. THEY PICKED UP THE CANNULA. LOCATION: TRANSTHORACIC LA. PLACEMENT DATE: [REDACTED]. REMOVED: [REDACTED]. EVENT DATE: [REDACTED]. MANUFACTURER: MEDTRONIC. CANNULA TYPE: DLP MALLEABLE SINGLE STAGE VENOUS CANNULA. SIZE: 20 FR.. LOT#: 0231369022. EXPIRATION DATE:05/21/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854119 DLP CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MEDTRONIC, INC. 0231369022

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male