BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0

    MDR report key: 6572758 · Received May 17, 2017

    Report

    Report Number
    3007042319-2017-01493
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 19, 2017
    Report Date
    October 11, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES INVOLVED IN THIS EVENT: BATTERY / (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    BAT208778. (B)(4). DEVICE EVALUATED BY MFR? YES. MFR. DATE: 09/30/2015. (B)(4). AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED SECTIONS HAVE BEEN UPDATED ACCORDINGLY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY: (B)(4). RETURNED ON 16-JUN-2017. EVALUATION IN PROGRESS. HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY: (B)(4). RETURNED ON 16-JUN-2017. EVALUATION IN PROGRESS. HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY: (B)(4). RETURNED ON 16-JUN-2017. EVALUATION IN PROGRESS. HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY: (B)(4). RETURNED ON 16-JUN-2017. EVALUATION IN PROGRESS. HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY: (B)(4). RETURNED ON 16-JUN-2017. EVALUATION IN PROGRESS. HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY: (B)(4). NOT RETURNED TO MANUFACTURER. HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY: (B)(4). CATALOG NUMBER 1650DE / EXPIRATION DATE: 30-SEP-2016. RETURNED ON 23-JUN-2017. EVALUATION IN PROGRESS. (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES FOR THIS COMPLAINTS: BAT214585 - 1650DE - EXP. DATE: 02/28/2017, BAT218965 - 1650DE - EXP. DATE: 06/30/2017, BAT215986 - 1650DE - EXP. DATE: 03/31/2017, BAT215166 - 1650DE - EXP. DATE: 02/28/2017, BAT219041 - 1650DE - EXP. DATE: 06/30/2017, BAT201332 - 1650DE - EXP. DATE: 10/31/2015. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. THE CONTROLLER IS A MICROPROCESSOR UNIT THAT CONTROLS AND MANAGES THE SYSTEM. IT SENDS POWER AND OPERATING SIGNALS TO THE BLOOD PUMP AND COLLECTS INFORMATION FROM THE PUMP. THE CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION: EITHER TWO BATTERIES, OR ONE BATTERY AND AN AC ADAPTER OR DC ADAPTER. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. THEY ALSO OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER IN ORDER TO PREVENT DAMAGES. IT IS OUTLINED TO INSPECT THE POWER CONNECTIONS AND PINS ONCE A WEEK, ONE AT A TIME WHEN CHANGING THE POWER SOURCE. THE IFU FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE DEVICE LABELING WARNS THAT DISCONNECTING THE CONTROLLER FROM THE DRIVELINE AND DISCONNECTING BOTH POWER SOURCES (BATTERIES AND AC OR DC ADAPTER) AT THE SAME TIME WILL STOP THE PUMP. AT LEAST ONE POWER SOURCE MUST BE CONNECTED AT ALL TIMES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. PRODUCT HAS BEEN NOT RETURN.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING EVENTS. ONE CONTROLLER ((B)(4)) AND SIX BATTERIES ((B)(4)) WERE RETURNED FOR EVALUATION. ONE BATTERY ((B)(4)) WAS NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. REVIEW OF THE (B)(4) MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. AN ATTEMPT WAS MADE TO REPLICATE THE ISSUE BY MANIPULATING THE BATTERIES' CONNECTION TO THE CONTROLLER DURING THE ANALYSIS OF THE UNITS. RESULTS REVEALED THAT THE ELECTRICAL CONNECTIONS BETWEEN THE BATTERIES AND CONTROLLER WERE STABLE. THE MANUFACTURER HAS OPENED AN INVESTIGATION WITH THE SUPPLIER TO EVALUATE THE MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED THE SMR SOFTWARE. THE SOFTWARE UPGRADE CONTAINS A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4) AND POWER SWITCHING DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. (B)(4)- MFR. DATE: 02/28/2016. DI#: (B)(4). DEVICE EVALUATED BY MFR: YES. MFR. DATE: 02/28/2016. (B)(4). DI#: (B)(4). DEVICE EVALUATED BY MFR: YES. MFR. DATE: 06/30/2016. (B)(4). DI#: (B)(4). DEVICE EVALUATED BY MFR: YES. MFR. DATE: 03/31/2016 (B)(4). DI#:(B)(4). DEVICE EVALUATED BY MFR: YES . MFR. DATE: 02/28/2016. (B)(4). DI#:(B)(4). DEVICE EVALUATED BY MFR: YES . MFR. DATE: 06/30/2016. (B)(4). DI#: (B)(4). DEVICE EVALUATED BY MFR: YES. MFR. DATE: 10/31/2014. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED ABOUT POWER SWITCHING. ALL SUSPECTED DEVICES INVOLVED IN THIS INCIDENT WERE EXCHANGED. THERE WERE NO REPORTED PATIENT CONSEQUENCES ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354963 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0 CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1