BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING, PUMP, CARDIOPULMONARY BYPASS22

    MDR report key: 9179546 · Received October 11, 2019

    Report

    Report Number
    1718850-2019-00016
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Report Date
    April 21, 2020
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWF
    UDI-DI
    00803622123313
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA HAS RECEIVED REPORTS OF WYES CONNECTORS PRESENTING A FILM INSIDE ONE OF Y LIMBS. VISUAL INSPECTION OF THE INTERIOR OF TWO RETURNED WYES CONNECTORS FOUND TO HAVE FLASH INSIDE DUE TO A MOLDING PARTIALLY OCCLUDING ONE BRANCH OF EACH CONNECTOR. THE EXTERIOR OF BOTH CONNECTORS DID NOT SHOW ANY DAMAGE OR DEFECTS. SIMULATED HIGH FLOW TEST PERFORMED WITH BOTH RETURNED CONNECTORS CONFIRMED THE FLOW THROUGH THE OCCLUDED BRANCHES WAS RESTRICTED AND TURBULENT. THE OCCLUDING MATERIAL DID NOT DETACH. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATION RELEVANT TO THE REPORTED ISSUE. NO OTHER SIMILAR COMPLAINT HAS BEEN RECEIVED FOR THE CLAIMED LOT. THE INVESTIGATION CONFIRMED THE REPORTED EVENT: THE WYES CONNECTORS WERE FOUND TO HAVE FLASH DUE TO MOLDING. THE HEALTH HAZARD EVALUATION ASSESSED THE RESIDUAL RISK RESULTED ACCEPTABLE. THIS TYPE OF WYE CONNECTORS IS SUPPLIED TO LIVANOVA BY SUPPLIER. THE SUPPLIER HAS BEEN INFORMED OF THE ISSUE. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA USA HAS RECEIVED REPORTS OF Y CONNECTORS PRESENTING A FILM INSIDE ONE OF Y LIMBS. THE ISSUE OCCURRED AT SETUP, PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974667 TUBING, PUMP, CARDIOPULMONARY BYPASS22 COBE SMARXT TUBING AND CONNECTORS DWF LIVANOVA USA INC CONNECTOR 1900300179 00803622123313

    Patients

    Seq Age Sex Outcome Treatment
    1