BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 9411051 · Received December 4, 2019

    Report

    Report Number
    3003761017-2019-00353
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 16, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE DRIVER REVEALED PHYSICAL DAMAGE TO THE FRONT AND REAR HOUSINGS. IN AN ATTEMPT TO REPRODUCE THE CUSTOMER-REPORTED ISSUE, A DUMMY BATTERY EXTRACTION TEST WAS PERFORMED ON THE DRIVER. WITHOUT INSERTING AN ONBOARD BATTERY, THE DUMMY BATTERY WAS REMOVED FROM THE DRIVER'S LEFT BATTERY WELL AND INSERTED IN THE RIGHT BATTERY WELL, AND THEN AGAIN REMOVED FROM THE RIGHT BATTERY WELL, THUS CONFIRMING THE CUSTOMER-REPORTED ISSUE. IT IS POSSIBLE TO REMOVE A DUMMY BATTERY IF THE DUMMY BATTERY IS WIGGLED ENOUGH. THIS IS DUE TO ITS SKELETON STRUCTURE AND LACK OF WALLS OR SKIN. HOWEVER, THE PURPOSE OF THE DUMMY BATTERY IS TO BE ABLE SHUT DOWN A FREEDOM DRIVER THAT IS NOT IN USE AND THE DUMMY BATTERY SHOULD ONLY BE REMOVED FROM THE BACKUP FREEDOM DRIVER AFTER INSERTING AN ONBOARD BATTERY. IT IS NOT PROPER PROCEDURE TO REMOVE THE DUMMY BATTERY WITHOUT A FREEDOM BATTERY IN THE FREEDOM DRIVER AND IT IS ADVISED AGAINST PER F-900013-EN, FREEDOM DRIVER SYSTEM OPERATOR MANUAL - US. SECTION 1.3.13 DUMMY BATTERY STATES THE FOLLOWING: · THE DUMMY BATTERY SHOULD ONLY BE REMOVED FROM THE BACKUP FREEDOM DRIVER AFTER INSERTING AN ONBOARD BATTERY WHEN SWITCHING THE PRIMARY FREEDOM DRIVER TO THE BACKUP FREEDOM DRIVER BECAUSE OF A FAULT ALARM THAT CANNOT BE RESOLVED. THE DRIVER PASSED ALL SECTIONS OF FUNCTIONAL TESTING AND PERFORMED AS INTENDED WITH NO EVIDENCE OF A DEVICE MALFUNCTION. 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.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE FREEDOM DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER ONBOARD BATTERY LATCH WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208092 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1