BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 8591290 · Received May 8, 2019

    Report

    Report Number
    9611109-2019-00330
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 8, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THE FIELD SERVICE REPRESENTATIVE REPLACED THE MOTOR END STAGE BOARD HMF 0408 AND SUBSEQUENT FUNCTIONAL VERIFICATION TESTING FOUND NO FURTHER ISSUES. THE ISSUE WAS SOLVED AND THE DEVICE WAS RETURNED TO SERVICE. THE REPLACED PART WAS REQUESTED BACK TO LIVANOVA (B)(4) FOR FURTHER INVESTIGATION. THE REPORTED ISSUE COULD BE REPRODUCED AND TRACED BACK TO A DEFECTIVE TRANSISTOR. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT ROTATING THE PUMP ROTOR MANUALLY IN THE DIRECTION OPPOSITE TO THE OPERATIONAL ONE WHEN A S5 ROLLER PUMP WAS OFF, NO ALARM SOUNDED. THIS WAS IDENTIFIED BY A LIVANOVA FIELD SERVICE REPRESENTATIVE DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384685 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1