BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    MDR report key: 4352373 · Received December 11, 2014

    Report

    Report Number
    3003761017-2014-00286
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DID NOT PREVENT THE COMPANION 2 FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIER AND COMPANION BATTERIES WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN SUPPLEMENTAL MDRS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES THE SYNCARDIA COMPANION 2 DRIVER AND TWO COMPANION EXTERNAL BATTERIES AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: COMPANION 2 DRIVER S/N (B)(4) (MFR REPORT #3003761017-201-00283); COMPANION EXTERNAL BATTERY S/N (B)(4); AND COMPANION EXTERNAL BATTERY S/N (B)(4) (MFR REPORT #3003761017-2014-00287). THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER DISPLAYED AN "EMERGENCY BATTERY LOW" ALARM AND ALL BATTERY INDICATOR LIGHTS WERE RED WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER "EMERGENCY BATTERY LOW" ALARM RESOLVED WITHIN SECONDS AND ALL COMPANION EXTERNAL BATTERY LIGHTS WERE GREEN.

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES THE SYNCARDIA COMPANION 2 DRIVER AND TWO COMPANION EXTERNAL BATTERIES AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: (1) COMPANION 2 DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2014-00283); (2) COMPANION EXTERNAL BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2014-00286); AND (3) COMPANION EXTERNAL BATTERY S/N (B)(4) (MFR REPORT # 3003761017-2014-00287). THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER DISPLAYED AN "EMERGENCY BATTERY LOW" ALARM AND ALL BATTERY INDICATOR LIGHTS WERE RED WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER "EMERGENCY BATTERY LOW" ALARM RESOLVED WITHIN SECONDS AND ALL COMPANION EXTERNAL BATTERY LIGHTS WERE GREEN. COMPANION EXTERNAL BATTERY S/N (B)(4) WAS RETURNED AS A PRECAUTIONARY MEASURE, TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE ROOT CAUSE OF THE "EMERGENCY BATTERY LOW" ALARM REPORTED IN COMPANION 2 DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2014-00283). AN INVESTIGATION WAS CONDUCTED AND THE ROOT CAUSE OF THE CUSTOMER REPORTED ALARM WAS A MALFUNCTION OF THE POWER MANAGEMENT PISTON CYLINDER ASSEMBLY (PCA) ON THE COMPANION 2 DRIVER. REVIEW OF THE INCOMING INSPECTION RECORD FOR THE EXTERNAL BATTERY REVEALED NO ANOMALIES. THE BATTERY MET ALL MANUFACTURING PROCEDURES AND INCOMING INSPECTION CRITERIA PRIOR TO BEING PLACED IN FINISHED GOODS. A VISUAL AND MECHANICAL INSPECTION OF THE BATTERY WAS PERFORMED AND NO PHYSICAL ANOMALIES WERE FOUND. THE BATTERY WAS TESTED IN ACCORDANCE WITH (B)(4), COMPANION EXTERNAL BATTERY EVALUATION PROCEDURE, AND PASSED ALL FINAL PERFORMANCE TESTING. THE BATTERY PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A MALFUNCTION. THE INVESTIGATION CONFIRMED THAT THE BATTERY WAS NOT THE ROOT CAUSE OF THE CUSTOMER REPORTED "EMERGENCY BATTERY LOW" ALARM AS DESCRIBED IN MFR REPORT # 3003761017-2014-00283. THE BATTERY MET ALL INSPECTION AND TESTING ACCEPTANCE CRITERIA AND WILL BE RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804091 SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK BATTERY PACK LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR