BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLENPUMPE 150

    MDR report key: 20023655 · Received August 21, 2024

    Report

    Report Number
    9611109-2024-00376
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 23, 2024
    Report Date
    October 29, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 SEPTEMBER 24, 2016 WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. H.11. COMPLAINTS DATABASE ANALYSIS REVEALED NO SIMILAR EVENT SINCE UNIT INSTALLATION IN 2006. THE ROOT CAUSE OF THE REPORTED FAILURE CAN BE ADDRESSED BY A DEFECTIVE HKR 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

    A.1.-A.5. PATIENT INFORMATION WERE NOT PROVIDED. A LIVANOVA SERVICE TECHNICIAN WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND IN ORDER TO SOLVE THE ISSUE COMPUTER BOARD (HKR) OF THE INVOLVED ROLLER PUMP WAS REPLACED. UNIT WAS TESTED AND NO OTHER DEFICIENCY WAS FOUND. 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 HAS RECEIVED A REPORT THAT THE ROLLER PUMP DISPLAYED MOTOR CONTROL FAILURE ERROR (E433). THE EVENT OCCURRED DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397434 S5 ROLLENPUMPE 150 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND GMBH 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown