BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER2.0

    MDR report key: 6865471 · Received September 14, 2017

    Report

    Report Number
    3007042319-2017-03137
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    July 24, 2017
    Report Date
    October 22, 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 · 0

    PRODUCT EVENT SUMMARY: THE RETURNED CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING, PASSING ALL TESTS. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: (B)(4) D10: 2017-11-20 H3: YES H6: FDA METHOD CODE(S): 3372, 10, 23, 38 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4). D10: 2017-12-05 H3: YES H6: FDA METHOD CODE(S): 3372, 38, 10, 23 H6: FDA RESULTS CODE(S): 3213, 213 H6: FDA CONCLUSION CODE(S): 25, 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4). D10: YES, 2017-12-31 H3: YES H6: FDA METHOD CODE(S): 3372, 10, 23, 38 H6: FDA RESULTS CODE(S): 3213, 213 H6: FDA CONCLUSION CODE(S): 71, 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4). D10: 2017-12-31 H3: YES H6: FDA METHOD CODE(S): 3372, 38, 10, 23 H6: FDA RESULTS CODE(S): 3213, 213 H6: FDA CONCLUSION CODE(S): 25, 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4). H6: FDA METHOD CODE(S): 3372, 10, 38, 23 H6: FDA RESULTS CODE(S): 3213, 213 H6: FDA CONCLUSION CODE(S): 25, 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. 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. 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

    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. **ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: BATTERY/(B)(4)/ CATALOG NUMBER: 1650DE / EXPIRATION DATE:10/31/2017. DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). BATTERY/(B)(4)/ CATALOG NUMBER: 1650DE / EXPIRATION DATE:10/31/2017. DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). BATTERY/(B)(4)/ CATALOG NUMBER: 1650DE / EXPIRATION DATE:12/31/2017. DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). BATTERY/(B)(4)/ CATALOG NUMBER: 1650DE / EXPIRATION DATE:12/31/2017. DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). BATTERY/(B)(4)/ CATALOG NUMBER: 1650DE / EXPIRATION DATE:02/28/2017. DEVICE AVAILABLE FOR EVALUATION?:: 07/14/2016. YES RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY:THE CONTROLLER AND FIVE (5) 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. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT CONTAINED A SOFTWARE 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). IN ADDITION, LOG FILE ANALYSIS REVEALED A PREMATURE POWER SWITCHING EVENT DUE TO A COMMUNICATION ERROR INVOLVING (B)(4). (B)(4) WAS NOT INVOLVED IN PREMATURE SWITCHING EVENTS. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE MOMENTARY DISCONNECTIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROLLER WOULD CHANGE POWER SOURCES EARLIER THAN EXPECTED. THE CONTROLLER AND ASSOCIATED BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644620 HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER2.0 CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR