BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SC-HEART-LUNG-MACHINE

    MDR report key: 6522133 · Received April 26, 2017

    Report

    Report Number
    9611109-2017-00312
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    April 4, 2017
    Report Date
    February 1, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K002118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE COMPACT SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    A LIVANOVA FIELD SERVICE REPRESENTATIVE CONFIRMED THAT THE PUMP 4 DISPLAY LIT UP WITH AN E80 ERROR (SAE ERROR) UPON ANALYSIS. THE CONTROL DESK SHOWED SYSTEM 4 ERROR (PUMP 4 ERROR). HE THEN VERIFIED THE FUNCTIONALITY OF THE MOTOR CONTROL CARD CMS 9613 FOR PUMP 4 BY SWAPPING IT WITH THE CARD FOR PUMP 3. REPLACING THE SAE 97-103-603 IN PUMP 4 SHOWED NO CHANGE. THE FIELD SERVICE REPRESENTATIVE THEN VERIFIED THAT THE REPLACEMENT SAE WAS FUNCTIONAL AND REINSTALLED THE ORIGINAL SAE. HE THEN REPLACED THE COMMUNICATION PROCESSOR CARD CKR 9609 90-304-780 TO RESOLVE THE ISSUE. ALL ERRORS WERE CLEARED FROM THE UNIT. A FUNCTIONAL VERIFICATION WAS THEN PERFORMED SUCCESSFULLY. AN IN HOUSE INVESTIGATION ON THE RETURNED PART WAS PERFORMED AND THE REPORTED ISSUE WAS NOT CONFIRMED THROUGH VISUAL INSPECTION. THE ISSUE WAS MOST LIKELY CAUSED BY A DEFECTIVE COMMUNICATION PROCESSOR BOARD CKR 9609.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE COMPACT SYSTEM DISPLAYED AN ERROR MESSAGE AND THE ROLLER PUMP STOPPED WORKING DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE COMPACT SYSTEM DISPLAYED AN ERROR MESSAGE AND THE ROLLER PUMP STOPPED WORKING DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303192 SC-HEART-LUNG-MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS, PRODUCT DTQ LIVANOVA DEUTSCHLAND 55-00-00

    Patients

    Seq Age Sex Outcome Treatment
    1