BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 6884696 · Received September 21, 2017

    Report

    Report Number
    3003761017-2017-00187
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    September 18, 2017
    Report Date
    August 29, 2018
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE OCCURRENCE OF A SYSTEM MALFUNCTION ALARM AS REPORTED BY THE CUSTOMER WAS CONFIRMED THROUGH A REVIEW OF THE PATIENT FILE. ATTEMPTS TO REPRODUCE THE SYSTEM MALFUNCTION ALARM THROUGH NORMAL DRIVER OPERATION WERE UNSUCCESSFUL; HOWEVER, INVESTIGATIONAL TESTING OF THE KEY SWITCH PROVED THAT A SYSTEM MALFUNCTION ALARM CAN BE RECORDED IF THE KEY SWITCH IS IMPROPERLY OR INCOMPLETELY TURNED. IT IS LIKELY THAT THE KEY SWITCH WAS BUMPED OR IMPROPERLY TURNED ALL THE WAY, CAUSING THE SYSTEM MALFUNCTION ALARM. THE LIKELY ROOT CAUSE OF THE CUSTOMER-REPORTED ALARM WAS IMPROPER USE, AS TESTING INDICATED THAT THE KEY WAS MOST LIKELY LEFT IN THE KEY SWITCH DURING PATIENT SUPPORT. THE DRIVER PASSED ALL FUNCTIONAL TESTING AND WAS SUBJECTED TO AN ADDITIONAL 24-HOUR OBSERVATION RUN IN AN ATTEMPT TO OBSERVE A POSSIBLE MALFUNCTION, CHANGE IN PERFORMANCE, OR OCCURRENCE OF A SYSTEM MALFUNCTION ALARM. THE DRIVER PERFORMED AS INTENDED, NO ALARMS SOUNDED AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. HOSPITALS ARE INSTRUCTED TO REMOVE THE KEY FROM THE DRIVER DURING PATIENT SUPPORT. THE SYNCARDIA COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL (C2-900005) SECTION 6.3 STATES: "WHEN THE DRIVER IS ON, THE KEY MUST BE REMOVED FROM THE DRIVER TO PREVENT UNINTENDED INTERRUPTIONS TO DRIVER OPERATION. ONCE REMOVED, THE KEY MAY BE STORED IN A LOCATION DETERMINED BY THE CLINICAL STAFF." SECTION 12.9 AND SECTION 15.2.5 OF THE OPERATOR MANUAL ALSO STATE: "REMOVE THE KEY FROM THE KEY SWITCH WHEN THE DRIVER IS IN OPERATION. THE KEY CANNOT BE REMOVED WHEN THE DRIVER IS SWITCHED OFF" AND "REMOVE THE KEY FROM THE KEY SWITCH WHEN THE DRIVER IS IN OPERATION. THE KEY CANNOT BE REMOVED WHEN THE DRIVER IS SWITCHED OFF", RESPECTIVELY. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE COMPANION 2 DRIVER EXHIBITED A SYSTEM MALFUNCTION ALARM, IT CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED A SYSTEM MALFUNCTION ALARM WHILE SUPPORTING A PATIENT. THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP COMPANION 2 DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663312 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR