BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 11937399 · Received June 4, 2021

    Report

    Report Number
    9611109-2021-00303
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 24, 2021
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED PUMP IS INSTALLED SINCE 2020 AND ACCORDING TO THE REVIEW OF THE COMPLAINT DATABASE NO FURTHER EVENTS HAVE BEEN REPORTED FOR THIS UNIT. THE REPORTED ERROR MESSAGE CAN BE CAUSED BY: A DEFECTIVE MOTOR CONTROLLER BOARD (HMS 0409); A DEFECTIVE MOTOR AMPLIFIER BOARD (HMF 0408); A DEFECTIVE CAN COMMUNICATION BETWEEN THE HMS AN THE HMF BOARD. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE CUSTOMER'S FACILITY. THE UNIT WAS CHECKED ON SITE ACCORDING TO MAINTENANCE PROCEDURES AND NO DEVIATION WAS DETECTED: THE ROLLER PUMP WORKED AS EXPECTED AND WITHIN SPECIFICATION. THUS, HARDWARE MALFUNCTIONS CAN BE RULED OUT AS CAUSE OF THE EVENT. BASED ON THE ABOVE FACTS, IT CANNOT BE RULED OUT THAT THE ISSUE WAS CAUSED BY AN INTERMITTENT COMMUNICATION BETWEEN THE HMS AND HMF BOARD.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE S5 DOUBLE HEAD 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 POTENTIALLY INVOLVED COMPONENTS, MOTOR CONTROL BOARD AND MOTOR END-STAGE BOARD, WERE REPLACED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 DOUBLE HEAD PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE DURING BYPASS. THE USER TRIED TURNING OFF AND BACK ON THE DEVICE AS WELL AS THE S5 SYSTEM BUT THE ISSUE PERSISTED. THE PUMP WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE COULD BE COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835698 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-85-00

    Patients

    Seq Age Sex Outcome Treatment
    1