BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 19399967 · Received May 27, 2024

    Report

    Report Number
    9611109-2024-00232
    Event Type
    Malfunction
    Date Received
    May 27, 2024
    Date of Event
    April 29, 2024
    Report Date
    November 18, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN ULM, GERMANY. 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

    D.4 UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS NOT AVAILABLE FOR THIS PRODUCT AS IT IS A CLASS II MEDICAL DEVICE MANUFACTURED BEFORE (B)(6) 2016 WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. H.11. DEVICE CLEANED AND DISINFECTED. TESTING OF THE DEVICE CONFIRMED THE REPORTED ERROR COULD BE CONFIRMED: NO CONTROL IS POSSIBLE ON THE RIGHT HEAD (RIGHT PUMP DOES NOT ROTATE AND THE OPEN COVER ALARM IS NOT RECOGNIZED) BUT CHANGES IN MENU SETTINGS ARE POSSIBLE SWAPPING THE CONNECTORS OF PUMP A AND PUMP B ON THE HKR BOARD CAUSED REPORTED BEHAVIOUR THEREFORE HKR BOARD HAS TO BE REPLACED AFTER REPLACING HKR BOARD, THE ISSUE WAS NOT SOLVED SO MOTOR BOARDS (HMS BOARD, HMF BOARD) HAVE TO BE REPLACED AS WELL. A SERVICE QUOTATION FOR THE REPAIR HAS BEEN SENT TO THE CUSTOMER BUT APPROVED YET. ACCORDING TO THE COMPLAINTS DATABASE REVIEW NO FURTHER SIMILAR ISSUES HAVE BEEN SUBMITTED FOR THIS UNIT SINCE ITS INSTALLATION IN 2007. BASED ON THE ABOVE FACTS, THE ROOT CAUSE OF THE REPORTED ISSUE HAS BEEN TRACED BACK TO FAULTY ELECTRONICS OF HKR, HMS AND HMF BOARD. 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. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW UP, LIVANOVA WAS INFORMED THAT WHEN CUSTOMER TRIED TURNING THE KNOB OF THE PUMP, NOTHING HAPPENED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: SERVICE QUOTATION FOR THE REPAIR WAS APPROVED BY THE CUSTOMER, THEREFORE THE FOLLOWING PARTS WERE REPLACED IN ORDER TO SOLVE THE ISSUE REPORTED: MOTOR CONTROL BOARD (HMS); COMPUTER BOARD (HKR); NEW SPEAKER DUE TO THE UPDATED HKR BOARD REPLACED (INCOMPATIBILITY BETWEEN THE ORIGINAL SPEAKER AND THE NEW BOARD); CABLE SPEAKER; PUSH-RIVET. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE PUMP ON THE RIGHT OF A S5 DOUBLE HEAD PUMP DID NOT TURN DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    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
    1398797 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 10-85-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown