BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10244062 · Received July 8, 2020

    Report

    Report Number
    9611109-2020-00400
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 9, 2020
    Report Date
    July 7, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT STATED THAT: "THE LIVANOVA FIELD SERVICE TECHNICIAN DISPATCHED TO THE FACILITY WAS NO ABLE TO REPRODUCE THE REPORTED EVENT. THE PATIENT PUMP 1 (005-21-0074) WAS PROACTIVELY REPLACED, THE UNIT WAS THEN POSITIVELY TESTED AND RETURNED TO ITS REGULAR SERVICE. A COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO FURTHER COMPLAINTS HAVE BEEN SUBMITTED ABOUT THIS SPECIFIC ISSUE FOR THIS UNIT. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA MAINTAINS AND DOCUMENT PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT." PLEASE, CONSIDER THE ABOVE INFORMATION NOT VALID. THE CORRECT INFORMATION IS THE FOLLOWING: THE ENGINEER OF THE HOSPITAL, ROTATED MANUALLY THE STIRRING MECHANISM AND THE REPORTED ERROR DISAPPEARED. THE LIVANOVA FIELD SERVICE TECHNICIAN DISPATCHED TO THE FACILITY WAS NO LONGER ABLE TO REPRODUCE THE REPORTED EVENT. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 0

    (B)(4) FIELD SERVICE TECHNICIAN DISPATCHED TO THE FACILITY WAS NO ABLE TO REPRODUCE THE REPORTED EVENT. THE PATIENT PUMP 1 (005-21-0074) WAS PROACTIVELY REPLACED, THE UNIT WAS THEN POSITIVELY TESTED AND RETURNED TO ITS REGULAR SERVICE. A COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO FURTHER COMPLAINTS HAVE BEEN SUBMITTED ABOUT THIS SPECIFIC ISSUE FOR THIS UNIT. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, (B)(4) MAINTAINS AND DOCUMENT PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. 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.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. 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 HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR CODE ASSOCIATED TO THE STIRRER MOTOR DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708254 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1