BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 2994973 · Received March 4, 2013

    Report

    Report Number
    3003761017-2013-00026
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    August 11, 2012
    Report Date
    March 1, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CORRECTED THE CONNECTION OF CANNULAE TO DRIVELINES AND THE PATIENT'S SYMPTOMS RESOLVED OVER THE NEXT 24 HOURS. THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED NO LONG-TERM ADVERSE EFFECTS. THE PATIENT IS STILL IMPLANTED WITH THE TAH-T AND IS DOING WELL, CURRENTLY IN THE HOSPITAL SUPPORTED BY A FREEDOM DRIVER. SYNCARDIA PROVIDED ADDITIONAL TRAINING TO THE HOSPITAL STAFF ON THE PROPER CONNECTIONS FOR TRANSFERRING PATIENTS TO AND FROM THE CSS CONSOLE, AND TO AND FROM THE FREEDOM DRIVER. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6) 2012, SUPPORTED BY A CIRCULATORY SUPPORT SYSTEM (CSS) CONSOLE. HE WAS SUBSEQUENTLY SWITCHED TO A PORTABLE FREEDOM DRIVER. THE CUSTOMER REPORTED THAT ON (B)(6) 2012 THE TAH-T PATIENT WAS SWITCHED FROM A FREEDOM DRIVER TO A CSS CONSOLE. ON (B)(6) 2012, WHILE A PATIENT WAS IN THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY HE HAD SIGNS AND SYMPTOMS OF PULMONARY EDEMA AND HEMODYNAMIC INSTABILITY. THERE WAS A SIGNIFICANT DISCREPANCY OF LEFT AND RIGHT TAH-T CANNULAE TO THE CSS CONSOLE DRIVELINES INCORRECTLY: THE LEFT CANNULA WAS INSERTED INTO THE RIGHT CSS DRIVELINE, AND THE RIGHT CANNULA WAS INSERTED INTO THE LEFT CSS DRIVELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91480 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 7

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention