BEUDAMED
    FDA Adverse Event Summary report: N

    SORIN C5 SYSTEM

    MDR report key: 5777237 · Received July 7, 2016

    Report

    Report Number
    9611109-2016-00428
    Date Received
    July 7, 2016
    Date of Event
    June 15, 2016
    Report Date
    January 8, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K093882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN C5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE SORIN C5 SYSTEM BECAME UNRESPONSIVE DURING A PROCEDURE, THOUGH THE DISPLAY LOOKED FINE. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE C5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED ISSUE. THE SERVICE REPRESENTATIVE BROUGHT ALONG TOUCH PANEL DISPLAYS; HOWEVER, THE TOUCH PANEL DISPLAYS WERE NO COMPATIBLE. IT IS NOTED THAT THE MACHINES WERE PROCURED AND SUPPLIED IN 2013; HOWEVER, THE MACHINES WERE NOT INSTALLED UNTIL MID-2016 AS THE FACILITY WAS NOT COMPLETED. THEREFORE THE MACHINES ARE NO LONGER CONSIDERED UNDER WARRANTY. TOUCHSCREEN 97-103-616 (OLD VERSION) HAS BEEN UPGRADED/REVISED TO 97-103-617 (NEW VERSION). THESE TOUCHSCREENS ARE DIFFERENT; THEREFORE MULTIPLE COMPONENTS ARE REQUIRED TO BE EXCHANGED TO ENABLE FULL FUNCTIONALITY. IT IS NOTED THAT THE NEW VERSION WAS ORDERED; HOWEVER, THE OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS RECEIVED. NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE EVALUATED FOR REPORTABILITY AS REQUIRED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY MANUFACTURING DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA HAS COMPLETED AN RCI TO ADDRESS THIS ISSUE. THE RESULT OF THE INVESTIGATION DOES NOT PROVIDE ANY EVIDENCE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. LIVANOVA HAS DETERMINED THAT A CAPA IS NOT REQUIRED, AS THERE WAS NO PATIENT HARM REPORTED. LIVANOVA WILL CONTINUE TO MONITOR THIS ISSUE FOR TRENDS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE SORIN C5 SYSTEM BECAME UNRESPONSIVE DURING A PROCEDURE, THOUGH THE DISPLAY LOOKED FINE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428787 SORIN C5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 58-00-00

    Patients

    Seq Age Sex Outcome Treatment
    1