BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PERFUSION TUBING SET

    MDR report key: 8358210 · Received February 21, 2019

    Report

    Report Number
    1718850-2019-00006
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Report Date
    May 17, 2019
    Manufacturer
    LIVANOVA USA, INC
    Product Code
    DWE
    UDI-DI
    00803622132759
    PMA / PMN Number
    K981613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID WAS NOT PROVIDED. PATIENT BIRTH DATE WAS NOT PROVIDED. PATIENT WEIGHT WAS NOT PROVIDED. PATIENT DEATH DATE WAS NOT DISCLOSED. LIVANOVA HAS BEEN INFORMED THE EVENT OCCURRED ON (B)(6) 2017. EVENT DATE WAS NOT DISCLOSED. LIVANOVA HAS BEEN INFORMED THE EVENT OCCURRED ON (B)(6) 2017. (B)(6). SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION ABOUT THE EVENT FROM THE CUSTOMER. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. IT IS UNKNOWN HOW THE PATIENT DIED, HOW AND IF THE PRODUCT WAS INVOLVED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    NOR THE CLAIMED DEVICE NEITHER PICTURE WERE PROVIDED FOR EVALUATION TO LIVANOVA USA INC. ACCORDING TO INFORMATION, THE EVENT OCCURRED MORE THAN A YEAR BEFORE THE DATE LIVANOVA USA HAS BEEN INFORMED. ATTEMPTS WERE DONE TO CLARIFY THE SEQUENCE OF EVENTS BUT CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL EXPLANATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA IS NOT AWARE OF ANY OTHER SIMILAR COMPLAINT RELATED TO PRODUCT CODE. AVAILABLE INFORMATION DID NOT POINT OUT ANY DEVICE MALFUNCTION. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    LIVANOVA USA INC HAS RECEIVED VIA THE U.S. MAIL THE MEDWATCH REPORT # (B)(4) STATING THAT, DURING A PROCEDURE, WHILE APPLYING THE STOPCOCK/LUER LOCK OF THE INLET LINE OF THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) TO INFLOW CANNULA, THERE WAS AN AUDIBLE CRACKING SOUND AND AIR WAS BEING ENTRAINED. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153777 CUSTOM PERFUSION TUBING SET CARDIOPULMONARY BYPASS CUSTOM TUBING KIT DWE LIVANOVA USA, INC 1717700066 00803622132759

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death