BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 SYSTEM PRO VERSION

    MDR report key: 18986325 · Received March 27, 2024

    Report

    Report Number
    9611109-2024-00153
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 27, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    UDI-DI
    04033817902676
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 PUMP. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: THE INVOLVED COMPUTER BOARD (HKR) WAS NOT RETAINED FOR A DEEPER INVESTIGATION FOR THE FOLLOWING REASON: NO SHORT-TERM OR LONG-TERM TRENDS HAVE BEEN DETECTED FOR THE REPORTED TYPE OF FAILURE; REPORTEDLY, NO PATIENT IMPACT OCCURRED; SIMILAR PREVIOUS INSTANCES OF THE FAILURE WERE REPORTED AND ALREADY INVESTIGATED, FINDING THE POSSIBLE CAUSES THAT, DEPENDING ON THE SPECIFIC OCCURRENCE, CAUSED THE ISSUE. COMPLAINTS DATABASE ANALYSIS REVEALED NO SIMILAR EVENT SINCE UNIT INSTALLATION IN 2023. BASED ON THE COLLECTED INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT CAN BE TRACE BACK TO A DEFECTIVE COMPUTER BOARD (HKR). FAILURE OF ELECTRONIC BOARDS CAN BE RELATED TO MULTIPLE AND NOT DETERMINISTIC FACTORS SUCH AS EXPOSURE TO HEAT, DUST AND MOISTURE, ACCIDENTAL IMPACT (DROPS AND FALLS), AND POWER OVERLOADS/SURGES BUT ALSO TO VARIABILITY OF MICRO SUBCOMPONENTS.

    Additional Manufacturer Narrative · 0

    A LIVANOVA FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE AND WAS ABLE TO DUPLICATE ISSUE. TO SOLVE THE ISSUE, PUMP HEAD AND HKR BOARD WERE REPLACED AND ALL SYSTEM FLASHED TO BE COMPATIBLE. THE DEVICE WAS TESTED AND RETURNED TO CUSTOMER. 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

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 PUMP GAVE A 'MOTOR MONITORING /CONTROL FAILED' ERROR MESSAGE DURING PROCEDURE. PUMP WAS WORKING AND THE CUSTOMER COULD CLEAR THE ERROR MESSAGE, BUT IT RETURNED EVERY 15 MINUTES. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528187 S5 SYSTEM PRO VERSION CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 48-40-00Z 04033817902676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown