BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PERFUSION TUBING SET

    MDR report key: 8298028 · Received February 1, 2019

    Report

    Report Number
    1718850-2019-00004
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 3, 2019
    Report Date
    July 10, 2019
    Manufacturer
    LIVANOVA USA, INC
    Product Code
    DWE
    UDI-DI
    00803622113338
    PMA / PMN Number
    K981613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED TUBING WAS RETURNED TO LIVANOVA FOR INVESTIGATION. INSPECTION OF THE TUBING FOUND THE CONNECTION TO BE CONFORMING TO LIVANOVA SPECIFICATIONS: THE TIE WAS PRESENT AND SOLVENT APPROPRIATELY APPLIED. NO EVIDENCE OF ANY PROCESS DEVIATION WAS FOUND. DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE CLAIMED DEFECT. FREQUENCY OF THIS TYPE OF EVENT IS LOW (IMPROBABLE). LIVANOVA INVESTIGATION DID NOT IDENTIFY ANY DEVICE RELATED PROBLEM PATIENT OUTCOME WAS NOT ASSOCIATED TO ANY DEVICE PROBLEM.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    LIVANOVA USA HAS BEEN INFORMED THAT, DURING A BYPASS, THE TUBING CONNECTION ON THE OXYGENATOR INLET COMPLETELY DISCONNECTED. DURING FOLLOW UP INFORMATION, LIVANOVA USA HAS BEEN INFORMED THE PATIENT HAS DIED 2 DAYS AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89379 CUSTOM PERFUSION TUBING SET CARDIOPULMONARY BYPASS CUSTOM TUBING KIT DWE LIVANOVA USA, INC 1827000013 00803622113338

    Patients

    Seq Age Sex Outcome Treatment
    1 Death