BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 6476322 · Received April 10, 2017

    Report

    Report Number
    9611109-2017-00294
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 24, 2017
    Report Date
    September 13, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURER DATE PROVIDED IN THE INITIAL REPORT, SUBMITTED APRIL 120, 2017, WAS INCORRECT. THE CORRECT DEVICE MANUFACTURER DATE IS NOVEMBER 22, 2010. . LIVANOVA (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). THE REPLACED TOUCH SCREEN AND THE PROCESSOR BOARD WERE RETURNED TO LIVANOVA USA WHERE A VISUAL INSPECTION WAS ABLE TO CONFIRM THAT THE TOUCH SCREEN WAS CRACKED DUE TO EXTERNAL DAMAGE. AS THE ISSUE WAS CAUSED BY EXTERNAL DAMAGE RATHER THAN A DEVICE MALFUNCTION, LIVANOVA (B)(4) HAS DETERMINED THAT NO CORRECTIVE ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE S5 ROLLER PUMP. 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 CONFIRMED THE REPORTED ISSUE AND REPLACED THE TOUCH SCREEN AND THE PROCESSOR BOARD. SUBSEQUENT FUNCTIONAL TESTING DID NOT IDENTIFY FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE DISPLAY OF THE S5 ROLLER PUMP BECAME UNRESPONSIVE DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257110 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1