BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 MAST ROLLER PUMP

    MDR report key: 18353765 · Received December 19, 2023

    Report

    Report Number
    9611109-2023-00641
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 20, 2023
    Report Date
    August 16, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    UDI-DI
    04033817900474
    PMA / PMN Number
    K103762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING A DEEPER ANALYSIS, HYPOTHESIS OF EXTERNAL INTERFERENCE CAN BE RULED OUT SINCE THE AFFECTED PUMP TURNED OFF BUT IT DIDN'T RESTART ON ITS OWN, WHICH WOULD HAVE HAPPENED IN THE EVENT OF EXTERNAL INTERFERENCE. THEREFORE, CAN BUS INTERRUPTION THAT WAS MOST LIKELY DUE TO 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

    **UDI RELATED DATA QUALITY UPDATES ONLY** D2A. COMMON DEVICE NAME HAS BEEN CORRECTED IN THE DEDICATED SECTION. D2B. DEVICE PRODUCT CODE HAS BEEN CORRECTED IN THE DEDICATED SECTION." G.4 PMA/510(K) NUMBER HAS BEEN CORRECTED IN THE DEDICATED SECTION.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 MAST ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD NOT REPRODUCE THE REPORTED ISSUE. THE SERIAL READ-OUT OF THE INVOLVED PUMP (REAL TIME DEVICE PARAMETERS AND SETTING RECORDING FILE) WAS ANALYZED: AT 12:28 OF THE DATE OF THE EVENT AN ERROR CODE WAS STORED INDICATING THAT THE LEVEL MONITORING FUNCTION WAS TURNED OFF (WITHOUT UNLINKING IT). THIS COULD BE DUE TO A CAN BUS INTERRUPTION OR TO A MALFUNCTION OF THE CAN INTERFACE OF THE PUMP; AT 12:38 OF THE DATE OF EVENT AN ERROR CODE WAS STORED CONFIRMING THAT HAND-CRANK HAS BEEN PERFORMED WITHOUT SWITCHING OFF THE PUMP. THE ROOT CAUSE OF THE PUMP STOP WAS A CAN BUS INTERRUPTION THAT WAS MOST LIKELY DUE TO EXTERNAL INTERFERENCE FROM OTHER DEVICES OR AN INTERMITTENT FAILURE OF THE SYSTEM BOARDS (HEK 0411 AND B HEX 041). 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 THAT A S5 MAST ROLLER PUMP TURNED OFF BY ITSELF DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496832 S5 MAST ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 10-88-00 04033817900474
    2127805 S5 MAST ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 10-88-00 04033817900474

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown