BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 12547199 · Received September 29, 2021

    Report

    Report Number
    9611109-2021-00540
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 28, 2021
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: THE REPORTED ISSUE IS ASSOCIATED TO THE MOTOR BEARING DAMAGED BY THE CORROSION, WHICH CONSEQUENTLY DOES NOT ALLOW THE MOTOR SHAFT TO ROTATE. POSSIBLE CAUSES ARE WATER INFILTRATION OR WATER FORMATION DUE TO CONDENSATION OR HIGH TEMPERATURES AND HIGH LEVEL OF HUMIDITY IN THE STATIONARY PHASE. CAUSES RELATED TO ENVIRONMENTAL CONDITIONS.

    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). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. BOTH PATIENT PUMPS WERE FOUND TO HAVE A BEARING DAMAGE AND WILL BE REPLACED. 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 MESSAGE ASSOCIATED TO PATIENT PUMPS DURING MAINTENANCE. REPORTEDLY, THE DEVICE WAS NOT USED SINCE FEBRUARY 21, 2021. THERE WAS NO PATIENT INVOLVEMENT. PERFUSIONIST POINTED OUT THAT THIS UNIT WAS INOPERABLE AND HAD A NOTE ON THE SIDE STATING THAT THE UNIT RAN VERY LOUD AND HAD A PATIENT 2 EE22 ERROR. PER THE NOTE, UNIT HAS BEEN OUT OF SERVICE SINCE FEBRUARY 21, 2021. TURNED UNIT ON INITIALLY FOR PM. LOUD MOTOR BEARING NOISES WERE COMING FROM UNIT, SO WE TURNED IT OFF. OPENED UP COVERS, TURNED UNIT BACK ON TO EXAMINE WHICH MOTORS WERE AT FAULT. SUSPECT THE FOLLOWING: COLD PLEGIA MOTOR BEARINGS ARE DEFECTIVE (PN 005-21-0076), PATIENT 1 MOTOR BEARINGS ARE DEFECTIVE (PN 005-21-0074), PATIENT 2 MOTOR WAS SEIZED AND WOULD NOT SPIN - WE WERE ABLE TO GET THE MOTOR TO SPIN AFTER MANUAL MOVEMENT, BUT FOUND THAT MOTOR BEARINGS ARE DEFECTIVE (PN 005-21-0075).ALL PARTS NEED TO BE ORDERED AND WILL BE INSTALLED ON NEXT VISIT TO THIS ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446508 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown