BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRICAL VENOUS OCCLUDER (EVO)

    MDR report key: 19759243 · Received July 17, 2024

    Report

    Report Number
    9611109-2024-00318
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 18, 2024
    Report Date
    March 19, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DXC
    PMA / PMN Number
    K082344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE ELECTRICAL VENOUS OCCLUDER (EVO). THE INCIDENT OCCURRED IN YOKOHAMA-CITY, JAPAN. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    COMPLAINED DEVICE HAS BEEN TEMPORARILY RETURNED TO JP TECHNICIANS WORKSHOP TO BE REPAIRED BUT NO INFORMATION REGARDING REPAIR ACTIVITY HAS BEEN PROVIDED YET. FROM COMPLAINT DATABASE REVIEW FOR SIMILAR EVENTS THE PHOTO SENSORS (PN: 97-103-648) AND ACCESSORY SPARE PARTS ARE USUALLY REPLACED TO SOLVE THIS ISSUE. COMPLAINTS DATABASE REVIEW REVEALED THAT NO FURTHER ISSUE HAS BEEN SUBMITTED FOR THIS UNIT SINCE ITS MANUFACTURING DATE IN 2015. BASED ON ALL THE ABOVE, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT MAY BE TRACED BACK TO DEFECTIVE PHOTO SENSORS. 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 STATING THAT AN EVO (ELECTRONIC VENOUS OCCLUDER) CLAMP DISPLAYED AN ERROR CODE: "OCCLUDER 1 FAULT IN OCCLUDER (1537)". AFTER TURNING OFF AND RESTARTING THE POWER, THE ALARM DISPLAY DISAPPEARED. THE EVENT OCCURRED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500611 ELECTRICAL VENOUS OCCLUDER (EVO) CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DXC LIVANOVA DEUTSCHLAND 12-80-10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown