BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3221669 · Received July 1, 2013

    Report

    Report Number
    3003761017-2013-00067
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED THAT THE LEFT DRIVELINE TUBING THAT CONNECTED TO THE TRANSDUCER ON THE PRESSOR SENSOR BOARD WAS NOT MAKING PROPER CONTACT, CAUSING AN AIR LEAK. A RHYTHMIC HISSING SOUND WAS HEARD COMING FROM THE CONNECTOR TUBING AT THE M3 TRANSDUCER ON THE SENSOR BOARD PRINTED CIRCUIT ASSEMBLY. MANIPULATION OF THIS TUBE CAUSED THE LEFT DRIVE PRESSURE TO FLUCTUATE OUT OF RANGE, BUT NOT FOR A LONG ENOUGH PERIOD OF TIME TO TRIGGER AN ALARM. THE ROOT CAUSE OF THE REPORTED "LEFT PRESSURE INCORRECT" ALARMS WAS AN AIR LEAK IN THE LEFT DRIVELINE TUBING CONNECTION AT THE SENSOR BOARD. THROUGH NORMAL OPERATING VIBRATION, THE AIR LEAK INCREASED ENOUGH TO HAVE CAUSED THE INTERMITTENT ALARMS. THE MULTIPLE "LEFT PRESSURE INCORRECT" ALARMS IN THE ALARM HISTORY THAT OCCURRED ROUGHLY ONCE PER MINUTE AND LASTED LESS THAN A MINUTE SUPPORTS THIS FINDING. THE TUBING WAS REPLACED, AND THE DRIVER PASSED ALL FINAL PERFORMANCE TESTING. THIS FAILURE MODE POSED A LOW RISK TO THE PT BECAUSE IT DID NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVAL OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED "LEFT PRESSURE INCORRECT" ALARMS WHILE SUPPORTING A PT. THE CUSTOMER ALSO REPORTED THAT THE LEFT DRIVE PRESSURE WAS DROPPED AND RAISED IN AN EFFORT TO REMEDY THE ALARM, BUT THESE ACTIONS DID NOT RESOLVE THE ISSUE. THE PT WAS SWITCHED TO A BACKUP DRIVER WITHOUT ADVERSE IMPACT. THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVAL. REVIEW OF THE ELECTRONIC PT FILE REVEALED MULTIPLE "LEFT PRESSURE INCORRECT" ALARMS. THESE ALARMS OCCURRED APPROX ONCE PER MINUTE AND LASTED LESS THAN A MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297277 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1