BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 5115453 · Received September 30, 2015

    Report

    Report Number
    3003761017-2015-00316
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 21, 2015
    Report Date
    September 21, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE INTERNAL COMPONENTS OF THE DRIVER REVEALED A FRACTURED HOUSING BOSS AND RAISED INSERT, SECONDARY MOTOR OUT OF BOTTOM DEAD CENTER (BDC) POSITION, DAMAGE TO THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) IN THE AREA NEAR THE PRIMARY MOTOR AND DAMAGE TO THE ORANGE WIRE FERRULE. DAMAGE SPECIFIC TO THE MAIN PCBA WAS MOST LIKELY CAUSED BY THE OPERATIONAL SWITCH TO THE SECONDARY MOTOR AND CONTACT MADE BETWEEN THE MAIN PCBA AND PRIMARY MOTOR. BASED UPON THE DAMAGE OBSERVED DURING VISUAL INSPECTION, IT IS LIKELY THE DRIVER WAS SUBJECTED TO ROUGH HANDLING OR AN IMPACT SHOCK. TOP DEAD CENTER (TDC) POSITIONING OF THE CAM FOLLOWER ON THE SECONDARY MOTOR AS OBSERVED DURING VISUAL INSPECTION, INDICATES THE SECONDARY MOTOR WAS ACTIVATED. HOWEVER, IF THE FAULT CODE RECORDED FIRST BECAUSE OF BATTERY EXCHANGE ISSUES AS DESCRIBED IN THE CUSTOMER-REPORTED ISSUE, THEN THE FAULT CODE FOR THE OPERATION SWITCH TO THE SECONDARY MOTOR WOULD NOT HAVE BEEN RECORDED IN THE ELECTRONIC DATA. DESPITE THE CUSTOMER-REPORTED DIFFICULTY REMOVING THE ONBOARD BATTERY, NO VISUAL DAMAGE TO THE BATTERY WELLS OR LATCHES WAS OBSERVED AND BATTERY INSERTION/EXTRACTION TESTING WAS PERFORMED WITH NO OBSERVED ISSUES. THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL FUNCTIONAL TEST REQUIREMENTS, WHICH INCLUDED INSERTION AND REMOVAL OF BOTH ONBOARD BATTERIES, WHILE OPERATING ON THE PRIMARY MOTOR WITH NO ANOMALIES OR UNINTENDED ALARMS. THE DRIVER WAS ALSO TESTED ON THE SECONDARY MOTOR AND EXHIBITED AN ALARM, AS EXPECTED. ADDITIONALLY, AN ONBOARD BATTERY INSERTION/EXTRACTION TEST WAS PERFORMED WITH NO ISSUES. THE DRIVER PASSED ALL TEST REQUIREMENTS WITH NO ANOMALIES. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE THE PATIENT WAS HAVING DIFFICULTY EXTRACTING ONE OF THE FREEDOM ONBOARD BATTERIES FROM THE DRIVER BATTERY WELL. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS UNABLE TO EXTRACT THE ONBOARD BATTERY AFTER SEVERAL ATTEMPTS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE THE PATIENT WAS HAVING DIFFICULTY EXTRACTING ONE OF THE FREEDOM ONBOARD BATTERIES FROM THE DRIVER BATTERY WELL. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS UNABLE TO EXTRACT THE ONBOARD BATTERY AFTER SEVERAL ATTEMPTS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER HAD DIFFICULTY WITH ONBOARD BATTERY EXTRACTION, THE FREEDOM DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER HAS A REDUNDANT POWER SOURCE OF EXTERNAL WALL POWER. IN ADDITION, PATIENTS ARE PROVIDED WITH SEVERAL FREEDOM ONBOARD BATTERIES. THE FREEDOM DRIVER 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
    645091 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR