BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 6186362 · Received December 19, 2016

    Report

    Report Number
    3007042319-2016-04420
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 24, 2016
    Report Date
    October 15, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER DEVICES INVOLVED IN THIS EVENT: D4: BATTERY / (B)(4). H6: FDA CONCLUSION CODES: 4307 - 12 D4: BATTERY / (B)(4). H6: FDA CONCLUSION CODES: 4307 - 12 D4: BATTERY / (B)(4). H6: FDA CONCLUSION CODES: 4307 - 12 D4: BATTERY / (B)(4). H6: FDA CONCLUSION CODES: 4307 - 12 D4: BATTERY / (B)(4). H6: FDA CONCLUSION CODES: 4307 - 12 D4: BATTERY / (B)(4). H6: FDA CONCLUSION CODES: 4307 - 12 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING EVENTS. ONE CONTROLLER AND SEVEN BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. ANALYSIS OF THE CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE UNITS PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. AN ATTEMPT WAS MADE TO REPLICATE THE ISSUE BY MANIPULATING THE BATTERY'S CONNECTION TO THE CONTROLLER DURING THE ANALYSIS OF THE UNIT. RESULTS REVEALED THAT THE ELECTRICAL CONNECTION BETWEEN THE BATTERIES AND THE CONTROLLER WAS STABLE. 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. LOG FILE ANALYSIS REVEALED POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTION INVOLVING (B)(4). LOG FILE ANALYSIS REVEALED POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). HEARTWARE IS CURRENTLY INVESTIGATING THE ROOT CAUSES OF THE MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLERS AND THE BATTERIES. REVIEW OF THE LOG FILES REVEALS TEN (10) CONTROLLER POWER-UP EVENTS LOGGED SINCE (B)(6) 2016. THERE WERE SEVERAL MOMENTARY DISCONNECTIONS LOGGED PRIOR TO SOME OF THE CONTROLLER POWER UP EVENTS. THE MOST LIKELY ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES. SUPPLEMENTAL TESTING PERFORMED ON THIS CONTROLLER, WHICH INCLUDED THE TUG TEST ON THE CABLES OF THE POWER SOURCES THAT WERE PROVIDING POWER TO THE CONTROLLER DURING THE FUNCTIONAL TESTING CONFIRMS THAT THE CONNECTION BETWEEN THE POWER SOURCES AND THE CONTROLLER ARE RELIABLE AT THE BENCH TEST. LOG FILES ALSO REVEALED A CRITICAL BATTERY ALARM THAT WAS LOGGED ON BATTERY (B)(4). THE LOGS RECORDED A RELATIVE STATE OF CHARGE (RSOC) OF 148%, INDICATING A COMMUNICATION ERROR HAD OCCURRED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENTS CAN BE ATTRIBUTED MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARM CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND (B)(4). THE MOST LIKELY ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    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, INCLUDING TRANSPORTATION. 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. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. "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. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. NOTE: WHEN ONE BATTERY IS DEPLETED TO <25%, THE CONTROLLER WILL AUTOMATICALLY SWITCH TO THE OTHER BATTERY. WHEN THIS HAPPENS, AN INTERMITTENT "BEEP" WILL SOUND, THE ALARM INDICATOR ON THE CONTROLLER WILL BE YELLOW, AND A MESSAGE WILL BE DISPLAYED TO REPLACE THE DEPLETED BATTERY. IF THE BATTERY IS NOT CHANGED WITHIN 5 MINUTES, THE ALARM VOLUME WILL ESCALATE UNTIL THE BATTERY IS EXCHANGED WITH A FULLY CHARGED BATTERY. WHEN A DEPLETED BATTERY IS NOT EXCHANGED AND THERE ARE ONLY A FEW MINUTES OF BATTERY TIME REMAINING IN BOTH BATTERIES, A HIGH PRIORITY ALARM WILL SOUND, THE ALARM INDICATOR WILL FLASH RED AND THE MESSAGE ON THE CONTROLLER WILL DISPLAY "CRITICAL BATTERY 1" OR "CRITICAL BATTERY 2." IF THIS OCCURS, THERE ARE ONLY A FEW MINUTES OF POWER REMAINING BEFORE THE PUMP STOPS; THEREFORE, THE BATTERIES MUST BE REPLACED IMMEDIATELY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE DEVICES HAVE BEEN RETURNED; HOWEVER, IT IS UNKNOWN WHICH OF THESE WERE INVOLVED IN THE EVENT. THESE DEVICES WILL BE ANALYZED AND REPORTED AS REQUIRED. SERIAL # (B)(4), CATALOG # 1650DE, EXP. DATE: 05/31/2017, MFG. DATE: 05/31/2016: (B)(4). SERIAL # (B)(4), CATALOG # 1650DE, EXP. DATE: 04/30/2017, MFG. DATE: 04/30/2016: (B)(4). SERIAL # (B)(4), CATALOG # 1650DE, EXP. DATE: 06/30/2017, MFG. DATE: 06/30/2016: (B)(4). SERIAL # (B)(4), CATALOG # 1650DE, EXP. DATE: 04/30/2017, MFG. DATE: 04/30/2016: (B)(4). SERIAL # (B)(4), CATALOG # 1650DE, EXP. DATE: 01/31/2017, MFG. DATE: 01/31/2016: (B)(4). SERIAL # (B)(4), CATALOG # 1650DE, EXP. DATE: 02/28/2017, MFG. DATE: 02/28/2016: (B)(4). SERIAL # (B)(4), CATALOG # 1650DE, EXP. DATE: 04/30/2017, MFG. DATE: 04/30/2016: (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING EVENTS. ONE CONTROLLER AND SEVEN BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. ANALYSIS OF THE CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE UNITS PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. AN ATTEMPT WAS MADE TO REPLICATE THE ISSUE BY MANIPULATING THE BATTERY'S CONNECTION TO THE CONTROLLER DURING THE ANALYSIS OF THE UNIT. RESULTS REVEALED THAT THE ELECTRICAL CONNECTION BETWEEN THE BATTERIES AND THE CONTROLLER WAS STABLE. 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. LOG FILE ANALYSIS REVEALED POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTION INVOLVING BAT213292, BAT217590, BAT219335, BAT219335, BAT214538, BAT216742, BAT218593 AND BAT21722. LOG FILE ANALYSIS REVEALED POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING BAT219335, BAT216742, BAT214538, BAT217590, BAT217277 AND BAT218593. HEARTWARE IS CURRENTLY INVESTIGATING THE ROOT CAUSES OF THE MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLERS AND THE BATTERIES. REVIEW OF THE LOG FILES REVEALS TEN (10) CONTROLLER POWER-UP EVENTS LOGGED SINCE 10/31/2016 THROUGH 11/24/2016. THERE WERE SEVERAL MOMENTARY DISCONNECTIONS LOGGED PRIOR TO SOME OF THE CONTROLLER POWER UP EVENTS. THE MOST LIKELY ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES. SUPPLEMENTAL TESTING PERFORMED ON THIS CONTROLLER, WHICH INCLUDED THE TUG TEST ON THE CABLES OF THE POWER SOURCES THAT WERE PROVIDING POWER TO THE CONTROLLER DURING THE FUNCTIONAL TESTING; CONFIRMS THAT THE CONNECTION BETWEEN THE POWER SOURCES AND THE CONTROLLER ARE RELIABLE AT THE BENCH TEST. LOG FILES ALSO REVEALED A CRITICAL BATTERY ALARM THAT WAS LOGGED ON BATTERY BAT219335. THE LOGS RECORDED A RELATIVE STATE OF CHARGE (RSOC) OF 148%, INDICATING A COMMUNICATION ERROR HAD OCCURRED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENTS CAN BE ATTRIBUTED MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARM CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BAT219335. THE MOST LIKELY ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES. (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HOWEVER, AN INTERNAL INVESTIGATION HAS BEEN OPENED BY THE SUPPLIER TO EVALUATE LOOSE CONNECTOR AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONTROLLER CHANGED FROM ONE POWER PORT TO THE OTHER ONE BEFORE BATTERIES ARE DOWN TO 25 PERCENT. THERE WAS ALSO MULTIPLE SWITCHING ONE BEHIND THE OTHER WITH PUMP STOPS AND "CRITICAL BATTERY" ALARMS. THERE WERE SEVERAL POWER UPS REPORTED AS WELL. THE PATIENT WAS USING A WAIST PACK. THERE WAS NO CONSEQUENCE TO THE PATIENT.  A CONTROLLER EXCHANGE WAS PERFORMED. THE PATIENT TOLERATED THE EXCHANGE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837429 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1