BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA (SORIN)

    MDR report key: 7037481 · Received November 15, 2017

    Report

    Report Number
    MW5073384
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 10, 2017
    Manufacturer
    SORIN INC.
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF CARDIOPULMONARY BYPASS MACHINE DURING CABG FOR APPROX 4 MINUTES. PERFUSIONIST INITIALLY BELIEVED PROBLEM WAS WITH IMPELLER HEAD. EVALUATION BY BIO MED TECH INDICATED CABLE COMING FROM THE SCP CONTROL PANEL AND GOING INTO THE SCP DRIVE UNIT HAD BEEN PULLED OUT OF THE STRAIN RELIEF OF THE DRIVE UNIT. ALSO SCP DRIVE UNIT FOUND SOME OF THE CONNECTIONS INSIDE THE UNIT HAD BEEN PULLED UP. THEY WERE ALL STILL WAKING A CONNECTION BUT WERE NOT SEATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811186 LIVANOVA (SORIN) CARDIOPULMONARY BYPASS MACHINE DTQ SORIN INC. 60-01-50

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR