BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONTROL PANEL MRP

    MDR report key: 6892261 · Received September 25, 2017

    Report

    Report Number
    9611109-2017-00752
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 25, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE S5 CONTROL PANEL SM000015 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE DEVICE 28-95-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K071318). LIVANOVA (B)(4) MANUFACTURES THE S5 CONTROL PANEL MRP. 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 WAS ABLE TO CONFIRM THE REPORTED ISSUE AND TRACED THE FAILURE TO A FAULTY S5 CONTROL PANEL. THE PANEL WAS REPLACED TO RESOLVE THE ISSUE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE REPLACED DEVICE WAS RETURNED TO LIVANOVA (B)(4) FOR FURTHER EVALUATION. THE REPORTED ISSUE WAS CONFIRMED DURING TESTING. VISUAL INSPECTION IDENTIFIED BAD SOLDERING JOINTS ON AN INTERNAL CIRCUIT BORED, WHICH CAUSED THE REPORTED ISSUE. THE COMPONENT WAS RE-SOLDERED AND NO FURTHER ERRORS WERE DETECTED. THE BOARD WAS DISCARDED AS A PRECAUTION AND A NEW BOARD WAS INSTALLED. SUBSEQUENT TESTING DID NOT IDENTIFY FURTHER ISSUES AND THE DEVICE WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT AN S5 MAST ROLLER PUMP COULD NOT BE STARTED USING THE S5 CONTROL PANEL MRP AT THE BEGINNING OF THE PROCEDURE, THOUGH FLOW WAS DISPLAYED. SWITCHING THE PUMP DID NOT RESOLVE THE ISSUE. NO PATIENT WAS CONNECTED TO THE S5 SYSTEM WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672234 S5 CONTROL PANEL MRP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND SM000015

    Patients

    Seq Age Sex Outcome Treatment
    1