BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 MAST ROLLER PUMP

    MDR report key: 20426232 · Received October 11, 2024

    Report

    Report Number
    9611109-2024-00462
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 11, 2024
    Report Date
    December 12, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTQ
    UDI-DI
    04033817900474
    PMA / PMN Number
    K103762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: LIVANOVA DEUTSCHLAND MANUFACTURES S5 MAST ROLLER PUMP. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE. SERIAL READ OUT (REAL TIME DEVICE PARAMETERS AND SETTING RECORDING FILE) OF THE PUMP WAS COLLECTED FORM THE MASTER PUMP. TO SOLVE THE ISSUE, MOTOR CONTROLLER HMS 0409 AND HMF 0408, MOTOR POWER AMPLIFIER BOARD HMF 0408 WERE REPLACED. CLEAR NVMEM OF THE PUMP AND PANEL WAS PERFORMED. SOFTWARE WAS UPDATED TO REV. 4.1. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS MEDWATCH WAS INITIALLY SUBMITTED ON 10 OCTOBER 2024. THE 3ACK FAILED. THE REPORT IS BEING RESUBMITTED ON 11 OCTOBER 2024.

    Additional Manufacturer Narrative · 0

    H11: THE SERIAL READ-OUT OF THE ROLLER PUMP (REAL-TIME DEVICE PARAMETERS AND SETTING RECORDING FILE) WAS GATHERED AND ANALYZED. ERROR CODE 429 WAS CONFIRMED WHEN PUMP TURNED ON FROM EVENT STORED: 11.09.24@09:25:39.244 C1=MCAN 1ADH=PERMANENT_CURRENT_OFFSET THAT INDICATES THAT THE MEASURED CURRENT VALUE DIFFERS FROM SETPOINT. MOTOR CONTROL BOARD (HMS) BOARD OR FLAT RIBBON CABLE CONNECTING THE HMS TO MOTOR POWER AMPLIFIER BOARD (HMF) BOARD IS DEFECTIVE AND PRODUCING WRONG SIGNAL. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2019 AND NO OTHER SIMILAR EVENT HAS BEEN REPORTED, NEITHER CONCERNING TREND HAS BEEN IDENTIFIED. TAKING INTO ACCOUNT OUTCOME OF THE TECHNICAL SERVICE ACTIVITY, THE MOST LIKELY ROOT CAUSE OF THE REPORTED ISSUE HAS BEEN ASSIGNED TO ELECTRICAL FAILURE OF ONE OR BOTH OF THE REPLACED BOARDS.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, WHEN SWITCHING ON THE S5 SYSTEM, MASTER PUMP ALARM FAULT IN THE MOTOR CONTROL (429). THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326112 S5 MAST ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND GMBH 10-88-00 04033817900474

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown