BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 9522929 · Received December 27, 2019

    Report

    Report Number
    9611109-2019-01003
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    November 27, 2019
    Report Date
    February 4, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. THE PART WAS REQUESTED FOR FURTHER INVESTIGATION AT THE MANUFACTURER SITE. RESULTS REVEALED THAT THE BUZZER ON THE MOTOR POWER AMPLIFIER WAS NOT WORKING THEREFORE NO ALARM SOUND WAS EMITTED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. 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. 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
    1322256 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 48-40-00

    Patients

    Seq Age Sex Outcome Treatment
    1