BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 6868659 · Received September 15, 2017

    Report

    Report Number
    3007042319-2017-03160
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 21, 2017
    Report Date
    June 13, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS IDENTIFIED FOLLOWING THE CONVERSION OF COMPLAINT FILES FROM THE LEGACY COMPLAINT HANDLING SYSTEM FOLLOWING INTEGRATION AND IS BEING SUBMITTED TO REPORT ANALYSIS RESULTS. PRODUCT EVENT SUMMARY, CON301141: THE 2.0 CONTROLLER PASSED EXTERNAL VISUAL INSPECTION, SYSTEM RUNNING TEST AND ALL FUNCTIONAL CHECKS. ADDITIONAL PRODUCTS: CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY BAT201497 - BATTERY D10: YES, RETURN DATE: 2018-02-15 H3: YES H4: 2014-10-31 H6: METHOD CODE(S): 10, 23, 38, 3372 H6: RESULTS CODE(S): 213 H6: CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY BAT202167 - BATTERY D10: YES, RETURN DATE: 2017-09-19 H3: YES H4: 2014-10-31 H6: METHOD CODE(S): 10, 23, 38, 3372 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY BAT202230 - BATTERY D10: YES, RETURN DATE: 2017-09-20 H3: YES H4:2014-10-31 H6: METHOD CODE(S): 10, 23, 38, 3372 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY BAT202238 - BATTERY D10: YES, RETURN DATE: 2018-02-14 H3: YES H4: 2014-10-31 H6: METHOD CODE(S): 10, 23, 38, 3372 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY D4: BAT202642 - BATTERY D10: YES, RETURN DATE: 2017-09-20 H3: YES H4: 2014-11-31 H6: METHOD CODE(S): 10, 23, 38, 3372 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY D4: BAT202734 - BATTERY D10: YES, RETURN DATE: 2017-09-20 H3: YES H4: 2014-11-31 H6: METHOD CODE(S): 10, 23, 38, 3372 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY D4: BAT215005 - BATTERY D10: YES, RETURN DATE: 2017-09-19 H3: YES H4: 2016-02-28 H6: METHOD CODE(S): 10, 23, 38, 3372 H6: RESULTS CODE(S): 213 H6: CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY D4: BAT215036 - BATTERY D10: YES, RETURN DATE: 2017-09-20 H3: YES H4: 2016-02-28 H6: METHOD CODE(S): 10, 23, 38, 3372 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER D4: CAC011516 - CONTROLLER AC ADAPTER / DI# 00888707000864 D10: YES, RETURN DATE: 2017-10-04 H3: YES H6: METHOD CODE(S): 10, 23, 38 H6: RESULTS CODE(S): 213 H6: CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE CONTROLLER AC ADAPTER PASSED ALL TESTS AND WAS FOUND TO BE IN GOOD WORKING ORDER. CORRECTION: D1: HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER CAC016274 - CONTROLLER AC ADAPTER D10: YES, RETURN DATE: 2017-10-04 H3: YES H6: METHOD CODE(S): 10, 23, 38 H6: RESULTS CODE(S): 180 H6: CONCLUSION CODE(S): 77 PRODUCT EVENT SUMMARY: THE CAC PASSED FUNCTIONAL TESTING BUT FAILED VISUAL INSPECTION. 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 · 0

    THE CONTROLLER ((B)(4)), EIGHT BATTERIES (B(B)(4)), AND TWO ADAPTERS ((B)(4)) 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. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT THE CONTROLLER, ALL BATTERIES, AND (B)(4) PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF (B)(4) REVEALED A CONNECTOR WITH A WORN-OUT CENTER BLOCK; THE DEVICE PASSED FUNCTIONAL TESTING. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE CAC CONNECTOR DAMAGE EVENT MAY BE ATTRIBUTED TO FACTORS SUCH AS NORMAL WEAR OVER TIME OR IMPROPER HANDLING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4), CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA FILES REVEALED POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION UNDER (B)(4) TO EVALUATE CONTROLLER INTERMITTENT DISCONNECTIONS. 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

    ADDITIONAL DEVICES FOR THIS COMPLAINTS HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY, (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 10/31/2015. (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 10/31/2015. (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 10/31/2015. (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 10/31/2015. (B)(4). DEVICE AVAILABLE FIR EVALUATION:?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 11/31/2015. (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 11/31/2015. (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 02/28/2017. (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE/: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 02/28/2017. (B)(4). DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER. UNK CONTROLLER AC ADAPTER / CATALOG NUMBER 1430DE. DI #:UNK. DEVICE AVAILABLE FOR EVALUATION? NO. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER. UNK CONTROLLER AC ADAPTER / CATALOG NUMBER 1430DE. DI #:UNK. DEVICE AVAILABLE FOR EVALUATION?: NO. LABELED FOR SINGLE USE?: NO. (B)(4). 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED SECTIONS HAVE BEEN UPDATED ACCORDINGLY. THE CONTROLLER AC ADAPTER SERIAL NUMBERS WERE PROVIDED. DEVICE: CONTROLLER AC ADAPTER/CAC011516/CATALOG NUMBER 1430DE. (B)(4). DEVICE: CONTROLLER AC ADAPTER/CAC016274/CATALOG NUMBER 1430DE. (B)(4). 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 BY THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR THAT THE BATTERIES AND CONTROLLER ALTERNATING CURRENT (CAC) ADAPTERS WERE POWER SWITCHING ON THE CONTROLLER. IT WAS RECOMMENDED TO HAVE ALL COMPONENTS EXCHANGED. THE BATTERIES AND CONTROLLER WERE EXCHANGED AND THE CAC ADAPTERS ARE EXPECTED TO BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649975 HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC 1420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN VAD