BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOPPEL-ROLLENPUMPE 85

    MDR report key: 17404798 · Received July 27, 2023

    Report

    Report Number
    9611109-2023-00361
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    June 28, 2023
    Report Date
    April 18, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWB
    UDI-DI
    04033817900405
    PMA / PMN Number
    K210130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SEAL AROUND THE BASE OF THE HEAD CANNOT BE ORDERED. UNIT NEED TO BE SENT TO THE MANUFACTURER FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS REPORT WAS DUE ON NOVEMBER 22, 2023; HOWEVER, DUE TO A NETWORK DISRUPTION AT LIVANOVA, THE ABILITY TO SUBMIT MDRS WAS LOST ON NOVEMBER 19, 2023, BEFORE THIS REPORT WAS READY TO SUBMIT. THE REPORT WAS PREPARED AND SUBMITTED FOLLOWING RESTORATION OF THE LIVANOVA SYSTEMS.

    Additional Manufacturer Narrative · 0

    H10: THE AFFECTED PART WAS RETURNED TO LIVANOVA DEUTSCHLAND FOR A DETAILED INVESTIGATION. THE FOLLOWING PARTS NEED TO BE REPLACED: - PUMP HEAD COMPLETE - MOTOR POWER AMPLIFIER (HMF) BOARD - MOTOR CONTROL (HMS) BOARD - LOCKING RING - S5 CASE FOR DOUBLE ROLLER PUMP. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H10: IN ORDER TO SOLVE THE ISSUE THE FOLLOWING PARTS WERE ACTUALLY REPLACED: - PUMP HEAD COMPLETE; - MOTOR POWER AMPLIFIER (HMF) BOARD; - MOTOR CONTROL (HMS) BOARD; - LOCKING RING; - S5 CASE FOR DOUBLE ROLLER PUMP. IN ADDITION THE NVMEM WAS CLEARED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2016 AND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED. BASED ON THE AVAILABLE INFORMATION AND ACCORDING TO THE RESULTS OF INVESTIGATIONS CONDUCTED ON PREVIOUS SIMILAR INSTANCES OF THE FAULT, IT IS REASONABLE TO TRACE THE CASE BACK TO A FAILURE OF THE PUMP HEAD.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WERE NOT PROVIDED. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 DOPPLE ROLLER PUMP. THE INCIDENT OCCURRED IN UNITED STATES. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT THE DOPPLE ROLLER PUMP DISPLAYED MOTOR CONTROL FAIL PUMP ERROR DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263611 S5 DOPPEL-ROLLENPUMPE 85 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND GMBH 10-85-00 04033817900405
    756215 S5 DOPPEL-ROLLENPUMPE 85 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND GMBH 10-85-00 04033817900405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown