BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM ONBOARD BATTERY

    MDR report key: 7062080 · Received November 27, 2017

    Report

    Report Number
    3003761017-2017-00225
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 4, 2017
    Report Date
    October 15, 2018
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE THE BATTERY WAS IN THE BATTERY CHARGER AND NOT IN USE IN THE PATIENT'S FREEDOM DRIVER AT THE TIME OF THE CUSTOMER-REPORTED ISSUE. THE FREEDOM ONBOARD BATTERY WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL.

    Additional Manufacturer Narrative · 1

    PHYSICAL INSPECTION OF THE BATTERY REVEALED IT TO EXHIBIT CONNECTOR / HOUSING SEPARATION. IN AN ATTEMPT TO REPRODUCE THE CUSTOMER-REPORTED CONDITION (THE 'PRONGS' ON THE BOTTOM OF FREEDOM DRIVER ONBOARD BATTERY PULL OUTWARD WHEN PULLED OUT OF THE CHARGER), THE BATTERY WAS INSTALLED AND EXTRACTED THREE TIMES IN EACH BAY OF FREEDOM BATTERY CHARGER RETURNED WITH THE BATTERY. FOLLOWING THE INSTALLATION / REMOVAL CYCLING OF THE BATTERY, THE BATTERY TERMINALS WERE EXAMINED AND FOUND TO EXHIBIT CONNECTOR / HOUSING SEPARATION, THEREBY DUPLICATING AND CONFIRMING THE CUSTOMER-REPORTED ISSUE. THE ROOT CAUSE FOR THE CONNECTOR / HOUSING SEPARATION IS LIKELY THE RESULT OF A HIGH NUMBER OF INSERTION / EXTRACTION CYCLES THE BATTERY HAD ACCUMULATED DURING USE IN THE FIELD. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE "PRONGS" ON THE BOTTOM OF THE PATIENT'S FREEDOM ONBOARD BATTERY PULLED OUTWARD WHEN REMOVED FROM THE BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840485 SYNCARDIA FREEDOM ONBOARD BATTERY BATTERY LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR