BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONTROL PANEL MRP 150/85

    MDR report key: 7074192 · Received December 1, 2017

    Report

    Report Number
    9611109-2017-00944
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 2, 2017
    Report Date
    July 26, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    UDI-DI
    04033817900818
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE S5 CONTROL PANEL MRP. THE INCIDENT OCCURRED IN (B)(6). 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 HKR BOARD. THE TECHNICIAN REPLACED THE BOARD TO RESOLVE THE REPORTED ISSUE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE DEFECTIVE BOARD WAS REQUESTED FOR FURTHER EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    THE REPLACED HKR BOARD WAS RETURNED TO LIVANOVA (B)(4) FOR FURTHER INVESTIGATION. EVALUATION OF THE RETURNED DEVICE WAS ABLE TO REPRODUCE THE REPORTED FAILURE. NON-CONFORMING SOLDERING JOINTS WERE IDENTIFIED TO BE THE ROOT CAUSE OF THE ISSUE. THIS IS A KNOWN ISSUE AND A CORRECTIVE ACTION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 CONTROL PANEL CONTROL PANEL MRP GOT BLACK DURING PROCEDURE. THE CUSTOMER WAS NOT ABLE TO CONTROL THE PUMP HEAD DUE TO THIS ISSUE. 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
    854007 S5 CONTROL PANEL MRP 150/85 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 28-95-80 04033817900818

    Patients

    Seq Age Sex Outcome Treatment
    1