BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 7205056 · Received January 19, 2018

    Report

    Report Number
    9611109-2018-00062
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 20, 2017
    Report Date
    June 4, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INITIALLY IT WAS REPORTED THAT THE ISSUE IS RELATED TO A S5 SYSTEM WHICH WAS INCORRECT. THE CORRECT DEVICE IS A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS. 60-02-50, 60S08704. PMA/510K: K032213. DEVICE MANUFACTURE DATE: 24.01.2011.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REQUESTED THAT A REPLACEMENT SCP CONTROL PANEL BE PROVIDED TO BE INSTALLED BY THE USER. THE PANEL WAS PROVIDED AND SUCCESSFULLY INSTALLED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING FOUND NO FURTHER ISSUES. THE REPLACED DEVICE WAS RETURNED TO LIVANOVA USA FOR FURTHER INVESTIGATION. THE REPORTED ISSUE COULD NOT REPRODUCED DURING VISUAL INSPECTION AND FUNCTIONAL TESTING. AS THE ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED AND NO CORRECTIVE ACTIONS WERE IDENTIFIED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE ISSUE.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 SYSTEM DISPLAYED AN ERROR MESSAGE DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48564 CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-02-50

    Patients

    Seq Age Sex Outcome Treatment
    1