BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 7153353 · Received December 28, 2017

    Report

    Report Number
    9611109-2017-01050
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 1, 2017
    Report Date
    July 20, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE MODEL AND SERIAL NUMBER HAVE NOT BEEN PROVIDED. THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT IF MADE AVAILABLE. LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE PERFORMED A SERIAL READOUT OF THE DEVICE AND SENT IT TO LIVANOVA (B)(4) FOR FURTHER INVESTIGATION. 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

    AN ANALYSIS OF THE SERIAL READOUT PROVIDED BY THE LIVANOVA FIELD SERVICE REPRESENTATIVE WAS UNABLE TO CONFIRM THE REPORTED ISSUE. THE SERVICE REPRESENTATIVE WENT ON-SITE AND WAS ABLE TO TRACE THE FAILURE TO A SOFTWARE ISSUE. THE TECHNICIAN UPDATED THE SOFTWARE TO RESOLVE THE MALFUNCTION. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED FOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE CENTRIFUGAL PUMP 5 (CP5) DID NOT PUMP AS EXPECTED AND SUFFICIENT VOLUME COULD NOT BE DELIVERED TO THE PATIENT DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 1

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931292 CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND

    Patients

    Seq Age Sex Outcome Treatment
    1