BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ERC TUBING CLAMP / 620MM

    MDR report key: 12376404 · Received August 27, 2021

    Report

    Report Number
    9611109-2021-00476
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Report Date
    August 27, 2021
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED DUE TO A TYPING ERROR. MEDICAL DEVICE PROBLEM CODE HAS BEEN UPDATED DUE TO THE PREVIOUS BEING INCORRECT. H.10: THE UNIT HAS BEEN REMOVED FROM SERVICE AND REQUESTED BACK TO THE MANUFACTURER SITE FOR REPAIR. BASED ON PREVIOUS INVESTIGATION FINDINGS, THE MOST LIKELY ROOT CAUSE OF THE PROBLEM IS A DEFECTIVE CLAMP MOTOR. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H.10: WRONG DEVICE CODE WAS PROVIDED IN THE PREVIOUS REPORT. DEDICATED SECTION D.2 HAS BEEN UPDATED WITH THE CORRECT PRODUCT CODE (DTQ). THE SERIAL NUMBER OF THE AFFECTED CLAMP SHOWING TWO ERROR CODES WAS PROVIDED AND THE DEDICATED D.4 SECTION HAS BEEN UPDATED. THE H.4 SECTION WAS UPDATED ACCORDINGLY WITH THE MANUFACTURING DATE OF DEVICE.

    Additional Manufacturer Narrative · 0

    H.10: THE ERROR CODE E106 INDICATES: DEFECTIVE ERC MOTOR (THE MOTOR IS JAMMED BECAUSE OF MISALIGNMENT OR FOREIGN BODIES). THE ERROR CODE E109 INDICATES A MISSING IMPULSE TRANSMISSION FROM HALL SENSORS AT THE STATOR OF THE ERC, DUE TO: DEFECTIVE PHOTOELECTRIC BARRIER - DEFECTIVE HALL SENSORS - DEFECTIVE MOTOR THE UNIT WAS RETURNED TO THE MANUFACTURER SITE FOR REPAIR. THE MOTOR AND THE SPINDLE WERE REPLACED. AS PER EQUIPMENT MAINTENANCE INTERVENTION PREVENTION BOTH CIRCUIT BOARDS WERE REPLACED AS WELL AS THE POWER CABLE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. TAKING INTO ACCOUNT REPAIR ACTIVITY AND THE FACT THAT BOTH ERRORS DIPLAYED HAVE A DEFECTIVE ERC MOTOR AS POTENTIAL ROOT CAUSE, A DEFECTIVE ERC MOTOR WAS IDENTIFIED AS THE CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED INFORMATION OF ELECTRONIC CLAMP DISPLAY 2 ERROR MESSAGES E106 AND 109. NO PATIENT INVOLVEMENT REPORTED.

    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 S5 ERC TUBING CLAMP / 620MM. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNT THAT: THE ERC WAS USED IN COMBINATION OF S5 WITH SCP PANEL. THE DISPOSABLE USED IS A COMPETITOR ONES. 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 RECEIVED INFORMATION OF 2 ELECTRONIC CLAMP DISPLAY ERROR MESSAGES E106 AND 109. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278261 S5 ERC TUBING CLAMP / 620MM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND GMBH 60-05-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown