BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 6951259 · Received October 16, 2017

    Report

    Report Number
    3003761017-2017-00198
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    October 6, 2017
    Report Date
    October 6, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE PATIENT DATA FILE WAS REVIEWED AND REVEALED MULTIPLE LEFT PRESSURE INCORRECT ALARMS THUS CONFIRMING THE CUSTOMER-REPORTED ISSUE. DURING THE RECORDING OF THESE ALARMS, THE LEFT PRESSURE WAS CONSISTENTLY HIGHER THAN THE SET POINT, WHICH TRIGGERED THE ALARM WHEN OUT OF TOLERANCE, AND CONFIRMED THE CUSTOMER-REPORTED ISSUE. THE LEFT PRESSURE INCORRECT ALARM WAS REPRODUCED DURING INVESTIGATION TESTING. THE ROOT CAUSE OF THE ALARM WAS DETERMINED TO BE A MALFUNCTION OF THE LEFT ELECTRONIC PRESSURE REGULATOR. SYNCARDIA HAS AN OPEN CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO ADDRESS THIS ISSUE. 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 ALTHOUGH THE COMPANION 2 DRIVER EXHIBITED A LEFT PRESSURE INCORRECT 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 LEFT PRESSURE INCORRECT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP COMPANION 2 DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED A LEFT PRESSURE INCORRECT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT 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
    730267 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR