BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 7154498 · Received December 29, 2017

    Report

    Report Number
    9611109-2017-01056
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    December 5, 2017
    Report Date
    May 18, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE INCIDENT OCCURRED IN (B)(6) A LOAN DRIVE UNIT HAS BEEN PROVIDED TO THE CUSTOMER. 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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED ISSUE AND TRACED THE FAILURE TO A DEFECTIVE ATTACHMENT ARM. THE TECHNICIAN REPLACED THE PART AND ALSO RETIGHTENED THE CARRIAGE FIXING POST TO RESOLVE THE REPORTED ISSUE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP STOPPED CIRCULATING AND AN DISPLAYED AN ERROR MESSAGE DURING A PROCEDURE. THE USER SWITCHED OUT THE DRIVE UNIT TO CONTINUE THE CASE. THE REPLACED DRIVE UNIT WAS LATER TESTED ON A DIFFERENT CONSOLE AND THE SAME ERROR MESSAGE WAS DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934609 CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-01-00

    Patients

    Seq Age Sex Outcome Treatment
    1