BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEK DUO VENO-VENOUS CANNULA

    MDR report key: 24625437 · Received March 18, 2026

    Report

    Report Number
    1718850-2026-90003
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 16, 2026
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWF
    PMA / PMN Number
    K160257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G1: UPDATED G1 CONTACT OFFICE - MANUFACTURING SITE TO CARDIAC ASSIST INC. (B)(6).

    Additional Manufacturer Narrative · 0

    A.1.- A.5. PATIENT INFORMATION WAS NOT PROVIDED. D4. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. H11: THROUGH FOLLOW-UP COMMUNICATIONS, LIVANOVA LEARNED THAT THE CANNULA WAS USED FOR TWO (2) DAYS. AFTER THE CRACK WAS NOTICED, THE CANNULA WAS REPLACED WITH ANOTHER ONE. REPORTEDLY, THE CRACK DID NOT CAUSE ANY LEAKAGE OR FLOW ISSUE. IN ADDITION, THE CANNULA WAS SECURED WITHOUT A SUTURE RING. CUSTOMER REPORTEDLY DID NOT FIX THE PROXIMAL LEGS OF THE CANNULA TOGETHER DURING USE. LIVANOVA INITIATED AN INVESTIGATION. 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.

    Description of Event or Problem · 0

    LIVANOVA US RECEIVED REPORT OF A PROTEKDUO CANNULA WHICH CRACKED AT THE Y CONNECTOR DURING USAGE. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532409 PROTEK DUO VENO-VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF LIVANOVA USA INC. PROTEK DUO ECLS CANNULA 31FR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1