BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP 150

    MDR report key: 20889861 · Received December 10, 2024

    Report

    Report Number
    9611109-2024-00592
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 12, 2024
    Report Date
    February 24, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4 UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS NOT AVAILABLE FOR THIS PRODUCT AS IT IS A CLASS II MEDICAL DEVICE MANUFACTURED BEFORE SEPTEMBER 24, 2016, WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ROLLER PUMP 150. THE INCIDENT OCCURRED IN (B)(6), ITALY. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. DURING TROUBLESHOOTING, MOTOR POWER AMPLIFIER BOARD (HMF) AND MOTOR CONTROL BOARD (HMS) WERE REPLACE. HOWEVER, AFTER TEN (10) MINUTES OF CORRECT OPERATION THE SAME ISSUE OCCURRED ON THE PUMP. THEREFORE, COMPUTER BOARD (HKR) AND TOUCHSCREEN WERE REPLACED (THIS LAST ONE FOR COMPATIBILITY REASONS) AND MODULE WAS UPGRADED TO VERSION H1. IN ADDITION, MOTOR POWER AMPLIFIER BOARD (HMF) AND MOTOR CONTROL BOARD (HMS), REPLACED PREVIOUSLY, WERE RE-ASSEMBLED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING (30 MINUTES) WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE SERIAL READ-OUT OF THE PUMP (REAL TIME DEVICE PARAMETERS AND SETTING RECORDING FILE) WAS ANALYZED AND NO ERROR CODE WAS STORED ON DATE OF EVENT (B)(6) 2024). ERROR CODE 441 IS STORED INSTEAD ON (B)(6) AT 9:30 AND 15:24 (IN THIS SECOND CASE AT THE SAME TIME THERE IS ALSO A RUNAWAY_PEAK ERROR, WHICH COULD BE LINKED TO A HAND CRANK WITH THE PUMP ON BUT ALSO A PROBLEM ON THE MOTOR CONTROLLER BOARD), AND ALSO ON (B)(6) AT 9:57 AND 11:54 (IN THIS SECOND CASE THERE IS AN ERROR ON THE RAM BOX, A MEMORY IN WHICH THE MESSAGES ON THE CAN ARE STORED, THIS ERROR OCCURS IF BY CHANCE THE DEVICE TURNS OFF DURING TRANSMISSION). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2005 AND NO OTHER SIMILAR EVENT HAS BEEN REPORTED, NEITHER CONCERNING TREND HAS BEEN IDENTIFIED. BASED ON ALL THE GATHERED INFORMATION, THE MOST LIKELY ROOT CAUSE HAS BEEN ASSIGNED TO AN ELECTRICAL FAILURE OF THE COMPUTER CIRCUIT BOARD HKR 0325. FAILURE OF ELECTRONIC BOARDS CAN BE RELATED TO MULTIPLE AND NOT DETERMINISTIC FACTORS SUCH AS EXPOSURE TO HEAT, DUST AND MOISTURE, ACCIDENTAL IMPACTS (DROPS AND FALLS), AND POWER OVERLOADS/SURGES BUT ALSO TO VARIABILITY OF MICRO SUBCOMPONENTS. HOWEVER, THERE IS NO CONCERNING TREND FOR THIS KIND OF FAILURE.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP 150, USED AS A CARDIOPLEGIA ONE, GAVE AN ERROR MESSAGE (CODE E441) RELATED TO A FAULT IN MOTOR CONTROLLER, DURING PROCEDURE. THE INVOLVED PUMP WAS TURNED OFF AND ON AGAIN BY THE USER AND THE ERROR MESSAGE DISAPPEARED. HOWEVER, AT THE END OF THE PROCEDURE IT RE-APPEARED. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697221 S5 ROLLER PUMP 150 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown