BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCP DRIVE UNIT W/FAST CLAMP

    MDR report key: 18387629 · Received December 22, 2023

    Report

    Report Number
    9611109-2023-00657
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 29, 2023
    Report Date
    February 29, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWA
    UDI-DI
    04033817900931
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE CP5. THE INCIDENT OCCURRED IN USA. UNIT WAS INSPECTED BY FIELD SERVICE ENGENEED AND WAS I FOUND THAT THE CONTROL PANEL WAS NOT FULLY PLUGGED INTO THE CONSOLE BASE. WHEN CONNECTION WAS CORRECTED, EVERYTHING STARTED WORKING PROPERLY. UNLIKELY THAT THE ISSUE WAS CAUSED BY A NOT FULLY PLUGGES CONTROL PANEL IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE ERROR CODE E04 INDICATES THAT EPROM IS DEFECTIVE AND THE INVOLVED COMPONENT IS THE CPU BOARD. THE COMPLAINTS DATABASE REVIEW REVEALED THAT NO SIMILAR ISSUES HAVE BEEN SUBMITTED FOR THIS UNIT SINCE ITS INSTALLATION IN 2017. BASED ON THE ABOVE FACTS, THE MOST LIKELY ROOT CAUSE IS AN ELECTRICAL FAILURE, AS BAD/LOOSE CONNECTIONS, A FALSE CONTACT OR SOME OXIDIZED ELECTRONICS ON THE BOARD THAT WAS FIXED DURING CHECKS PERFORMED BY THE FSE DURING INSPECTION. 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.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE SCP PUMP KEEPS RESETTING THE RPM TO 1000 AND DISPLAYS ERROR EPROM DEFECTIVE (E04). THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264882 SCP DRIVE UNIT W/FAST CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND GMBH 60-01-00 04033817900931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown