BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 2911208 · Received December 12, 2012

    Report

    Report Number
    3003761017-2012-00095
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVAL, AND THE RESULTS OF THE INVESTIGATION ARE PROVIDED IN THE INVESTIGATION REPORT ATTACHED HERETO. THE ISSUE REPORTED BY THE CUSTOMER OF THE TOUCHSCREEN NOT FUNCTIONING WAS NOT ABLE TO BE DUPLICATED IN THE LAB AT SYNCARDIA. DURING INITIAL ASSESSMENT, THE TOUCHSCREEN FUNCTIONED AS INTENDED. HOWEVER, THE INVESTIGATION DID IDENTIFY MILK RESIDUE IN THE DRIVER, WHICH WAS MOST LIKELY THE CAUSE OF THE ISSUE REPORTED BY THE CUSTOMER. A VISUAL INSPECTION OF THE EXTERNAL COMPONENTS OF THE COMPANION 2 DRIVER IDENTIFIED MILK RESIDUE ON THE FRONT SKIN, TOUCHSCREEN, AND OUTER DIAMETER OF THE KEY SWITCH. THE DRIVER WAS DISASSEMBLED, AND A TRAIL OF MILK RESIDUE WAS OBSERVED LEADING FROM THE FRONT OF THE DRIVER ALONG THE BOTTOM RIGHT CORNER, POOLING IN THE REAR OF THE CASSIS. MILK RESIDUE WAS OBSERVED ALONG THE BOTTOM OF THE TOUCHSCREEN AND BETWEEN THE CPC DRIVELINE CONNECTOR BLOCK AND TOUCHSCREEN AND ON OTHER INTERIOR COMPONENTS, SUCH AS THE OUTER INSULATION OF MOTOR CONTROL CABLE B, THE EXTERNAL AIR REGULATOR KNOB, THE OUTSIDE OF THE LEFT VACUUM BLOWER, THE INSULATION OF THE REGULATOR WIRES AND THE FRONT END OF THE CHASSIS WELDMENT. DURING THE INVESTIGATION, TESTING REVEALED THAT THE INTERNAL EMERGENCY BATTERY WAS NOT FUNCTIONING AS INTENDED. THE EMERGENCY BATTERY WAS EVALUATED AND FOUND TO HAVE A PERMANENT FAULT, INDICATING A CHARGE SAFETY-OVERCURRENT CONDITION. THE CAUSE OF THE MALFUNCTIONING BATTERY WAS NOT THE RESULT OF THE MILK SPILL. THE INTERNAL EMERGENCY BATTERY WAS REPLACED, AND THE MALFUNCTIONING BATTERY WAS SENT TO A CONSULTING ELECTRICAL AND SOFTWARE ENGINEERING COMPANY FOR FURTHER EVAL. THE INTERFACE TOUCHSCREEN WAS REPLACED, AND ALL OTHER COMPONENTS WITH MILK RESIDUE WERE CLEANED USING REAGENT ALCOHOL AND A LINT FREE CLOTH. THE DRIVER WAS REASSEMBLED PER PROCEDURE AND THEN PASSED ALL FINAL PERFORMANCE TESTING. THE REPORTED COMPLAINT POSED A LOW RISK TO THE PT, BECAUSE IT DID NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. SYNCARDIA HAS COMPLETED ITS EVAL OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MILK WAS SPILLED ON THE USER INTERFACE OF THE COMPANION 2 DRIVER, AND THE TOUCHSCREEN WENT BLANK AND DID NOT RECOVER ITS FUNCTIONALITY. THE COMPANION 2 DRIVER CONTINUED TO PUMP AND PROVIDE PNEUMATIC SUPPORT TO THE PT. THE PT WAS TRANSFERRED TO A PORTABLE FREEDOM DRIVER LATER THAT DAY. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR