BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 19870260 · Received July 31, 2024

    Report

    Report Number
    9611109-2024-00336
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 2, 2024
    Report Date
    October 9, 2024
    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

    H11: COMPLAINTS DATABASE ANALYSIS REVEALED NO SIMILAR EVENT SINCE UNIT INSTALLATION IN 2015 AND NO ADVERSE AND CONCERNING TRENDS ABOUT THE REPORTED FAILURE MODE HAVE BEEN TRIGGERED BY PERIODICAL COMPLAINTS STATISTICAL ANALYSIS. THE SERIAL READ-OUT (REAL-TIME DEVICE PARAMETERS AND SETTING RECORDING FILE) OF THE S5 MAST ROLLER PUMP WAS PROVIDED AND ANALYZED, INDICATING TWO TEXT CODE OCCURRED: TIMEOUT_INTERVENTION AND RUNAWAY_PEAK. FOR TIMEOUT_INTERVENTION, FACTORS POTENTIALLY TRIGGERING THE ALARM ARE: - CONTROL FUNCTION ON THE PUMP SWITCHED OFF IMPROPERLY (WITHOUT UNLINKING IT); - FAILURE OF A DEVICE LINKED TO THE PUMP; - CAN BUS INTERRUPTION; - MALFUNCTION OF THE CAN INTERFACE OF THE PUMP. FOR RUNAWAY ERROR INSTEAD, THIS CAN BE DUE TO PUMP HAND-CRANKED OR MANIPULATED, BUT NOT SWITCHED OFF (USER ERROR). SINCE NO USER ACTION WAS PERFORMED AT TIME OF FAILURE THAT OCCURRED DURING FUNCTIONING, THE ROOT CAUSE OF THE PUMP STOP WAS RELATED TO A CAN BUS INTERRUPTION/MALFUNCTION. BASED ON THE ABOVE ANALYSIS AND INVESTIGATION RESULTS OF SIMILAR PREVIOUS COMPLAINTS, THE ROOT CAUSE OF THE PUMP STOP WAS A CAN BUS INTERRUPTION THAT COULD BE DUE TO EXTERNAL INTERFERENCES FROM OTHER DEVICES OR AN INTERMITTENT FAILURE OF THE SYSTEM BOARDS (HEK 0411 AND B HEX 041). HOWEVER, NO EVIDENCE OF OTHER DEVICE AFFECTED BY POSSIBLE ELECTROMAGNETIC INTERFERENCES WAS REPORTED AND LIVANOVA PRODUCTS ARE CERTIFIED TO BE DESIGNED ACCORDING TO ISO 60602.1.2 FOR ELECTROMAGNETIC COMPATIBILITY, CONSEQUENTLY A CAN BUS INTERRUPTION WAS THE MOST LIKELY ROOT CAUSE RELATED TO A FAILURE OF THE SYSTEM BOARDS (HEK 0411 AND B HEX 041). 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 SUB-COMPONENTS. HOWEVER, THERE IS NO CONCERNING TREND FOR THIS KIND OF FAILURE.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. D.4 ADDITIONAL 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. THE INCIDENT OCCURRED IN ITALY. THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, IT WAS LEARNED THAT INVOLVED ROLLER PUMP WAS TESTED ON A DIFFERENT CONSOLE DEVICE, AND NO ISSUE WAS DETECTED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT STATING THAT A S5 ROLLER PUMP STOPPED DURING SERVICE. THERE WERE NO ALARMS OR WARNINGS. THE CUSTOMER PROCEEDED WITH THE TOOL TO MOVE THE PUMP MANUALLY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241901 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown