BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7168891 · Received January 5, 2018

    Report

    Report Number
    3007042319-2018-00098
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 3, 2017
    Report Date
    August 21, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCTS: BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-12 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS NOT CONFIRMED. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-12 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS NOT CONFIRMED. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-12 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS NOT CONFIRMED. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-12 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 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

    PRODUCT EVENT SUMMARY: ONE CONTROLLER ((B)(4)) AND FOUR BATTERIES ((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 BATTERIES REVEALED THAT THE UNITS PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE CONTROLLER, (B)(4), REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS AROUND POWER PORTS 1 AND 2. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACKS WERE NOT RELATED TO THE REPORTED EVENT. AN INVESTIGATION WAS OPENED TO INVESTIGATE CRACKS OBSERVED ON CONTROLLER 2.0 IN THE AREA SURROUNDING THE POWER PORT CONNECTORS. THE LOG FILES OF THE CONTROLLER, (B)(4), REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. ANALYSIS OF DAT A LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4) AND SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). THESE POWER SWITCHING EVENTS WERE MOST LIKELY PERCEIVED BY THE PATIENT AS DISCONNECTIONS OF THE BATTERIES FROM THE CONTROLLER. ANALYSIS OF THE ALARM LOG FILE REVEALED SEVEN (7) CRITICAL BATTERY ALARM EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). AS A RESULT, THE REPORTED CRITICAL BATTERY ALARM AND BATTERY DISCONNECTION EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM EVENT CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED BATTERY DISCONNECTIONS MAY BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY 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

    PRODUCT EVENT SUMMARY: THE RETURNED CONTROLLER PASSED FUNCTIONAL TESTING BUT FAILED VISUAL INSPECTION. THE REPORTED EVENT WAS CONFIRMED. INVESTIGATION IS ONGOING. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: BATTERY (B)(4). PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED EVENT WAS CONFIRMED. INVESTIGATION IS ONGOING. 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 AND DESTINATION THERAPY 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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31 UDI #: (B)(4), MFG DATE: 2017-07-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31, UDI #: (B)(4), MFG DATE: 2017-07-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31, (B)(4), MFG DATE: 2017-07-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31, (B)(4), MFG DATE: 2017-07-31.(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR BATTERIES WOULD DISCONNECT FROM THE CONTROLLER POWER PORT AT DIFFERENT TIMES REQUIRING THE PATIENT TO RECONNECT THE BATTERIES. IT WAS ALSO REPORTED THAT THE BATTERIES EXHIBITED CRITICAL BATTERY ALARMS 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
    11623 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1407DE 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR 1104 VAD