BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    MDR report key: 5056914 · Received September 4, 2015

    Report

    Report Number
    3003761017-2015-00273
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4), 2 OF 4

    Description of Event or Problem · 1

    THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER FOUR SEPARATE MEDICAL DEVICE REPORTS: COMPANION EXTERNAL LI-BATTERY PACK S/N (B)(4) (MFR REPORT # 3003761017-2015-00272, COMPANION EXTERNAL LI-BATTERY PACK S/N (B)(4) (MFR REPORT # 3003761017-2015-00273), COMPANION EXTERNAL LI-BATTERY PACK S/N (B)(4) (MFR REPORT # 3003761017-2015-00274), AND COMPANION EXTERNAL LI-BATTERY PACK S/N (B)(4) (MFR REPORT # 3003761017-2015-00275). THE CUSTOMER REPORTED THAT THE COMPANION EXTERNAL BATTERIES IN AN UNPLUGGED COMPANION 2 DRIVER WERE LOSING CHARGE QUICKER THAN WHAT WAS DISPLAYED ON THE BATTERY GAUGE. THE CUSTOMER ALSO REPORTED THAT ALL FOUR EXTERNAL BATTERIES WERE TRIED ON THE SAME DRIVER WITH THE SAME RESULT. THE CUSTOMER ALSO REPORTED THAT THE COMPANION EXTERNAL BATTERIES IN THE PATIENT'S COMPANION 2 DRIVER WERE EXCHANGED WITHOUT ANY ADVERSE PATIENT IMPACT. COMPANION EXTERNAL BATTERY S/N (B)(4) WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE EXTERNAL BATTERY REVEALED NO ANOMALIES. THE EXTERNAL BATTERY WAS CONNECTED TO BATTERY EVALUATION SOFTWARE, AND REVIEW OF THE DATA REVEALED THAT THE EXTERNAL BATTERY WAS FUNCTIONAL, AND NO PERMANENT FAULTS WERE LOGGED. THE EXTERNAL BATTERY WAS FUNCTIONALLY TESTED AND PASSED ALL FUNCTIONAL TEST REQUIREMENTS. IN ADDITION, THE EXTERNAL BATTERY MET THE MINIMUM REQUIRED DISCHARGE DURATION OF 30 MINUTES. THE CUSTOMER-REPORTED ISSUE COULD NOT BE REPRODUCED DURING TESTING, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL (C2-900005), AT CHAPTER 13, "POWER MANAGEMENT," ADVISES USERS THAT WHEN FULLY CHARGED, EACH COMPANION EXTERNAL BATTERY PROVIDES A MINIMUM OF 30 MINUTES OF SUPPORT. TWO FULLY CHARGED EXTERNAL BATTERIES PROVIDE A MINIMUM OF 60 MINUTES OF SUPPORT. THE REPORTED ISSUE POSED A LOW RISK TO THE PATIENT BECAUSE IT DID NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER HAS REDUNDANT, ALTERNATE POWER SOURCES OF EXTERNAL WALL POWER AND AN INTERNAL, EMERGENCY BATTERY. IN ADDITION, ALL POWER SOURCES ARE CONTINUALLY MONITORED BY THE COMPANION 2 DRIVER, WITH AUDIBLE AND VISUAL ALARMS PROVIDED TO ANNUNCIATE ANY POTENTIAL ISSUES WITH THE DRIVER POWER SOURCES. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER FOUR SEPARATE MEDICAL DEVICE REPORTS: (1) COMPANION EXTERNAL LI-BATTERY PACK S/N 40408 (MFR REPORT # 3003761017-2015-00272, (2) COMPANION EXTERNAL LI-BATTERY PACK S/N (B)(4) (MFR REPORT # 3003761017-2015-00273), (3) COMPANION EXTERNAL LI-BATTERY PACK S/N (B)(4) (MFR REPORT # 3003761017-2015-00274), AND (4) COMPANION EXTERNAL LI-BATTERY PACK S/N (B)(4) (MFR REPORT # 3003761017-2015-00275). THE CUSTOMER REPORTED THAT THE COMPANION EXTERNAL BATTERIES IN AN UNPLUGGED COMPANION 2 DRIVER WERE LOSING CHARGE QUICKER THAN WHAT WAS DISPLAYED ON THE BATTERY GAUGE. THE CUSTOMER ALSO REPORTED THAT ALL FOUR EXTERNAL BATTERIES WERE TRIED ON THE SAME DRIVER WITH THE SAME RESULT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT SUBSEQUENTLY SWITCHED TO THE BACKUP COMPANION EXTERNAL BATTERIES WITHOUT ANY ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT SINCE THE LOW BATTERY DID NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER HAS A REDUNDANT, ALTERNATE POWER SOURCE OF EXTERNAL WALL POWER. THE COMPANION EXTERNAL BATTERIES WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587703 SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK BATTERY LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR