BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7427296 · Received April 12, 2018

    Report

    Report Number
    3007042319-2018-01438
    Event Type
    Injury
    Date Received
    April 12, 2018
    Date of Event
    March 13, 2018
    Report Date
    October 30, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL CHECKS. THE INVESTIGATION IS ON-GOING. 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: THE CONTROLLER WAS RETURNED FOR EVALUATION. ONE BATTERY AND ONE UNKNOWN CONTROLLER AC ADAPTER WERE NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE CONTROLLER IN RELATION TO THE REPORTED EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF BATTERY CONFIRMED THAT THE DEVICE MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS 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 THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS. ADDITIONALLY, ANALYSIS OF EVENT FILE REVEALED ONE CONTROLLER POWER UP FOLLOWED BY A MOTOR START EVENT THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT AN AC ADAPTER WAS CONNECTED TO POWER PORT ONE (1) AND BAT556690 WAS CONNECTED TO POWER PORT TWO (2) WITH 89% RELATIVE STATE OF CHARGE. THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT NO POWER SOURCE WAS CONNECTED TO POWER PORT (1) AND BAT555639 WAS CONNECTED TO POWER PORT TWO (2). THE CONTROLLER WAS WITHOUT POWER FOR 14 MINUTES AND 19 SECONDS. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND THE BATTERIES. MOMENTARY DISCONNECTIONS WERE INVESTIGATE INTERNALLY. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. ADDITIONAL PRODUCTS: BATTERY / BAT556690 . 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 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. PRODUCT EVENT SUMMARY: IN RELATION TO THE REPORTED EVENT, (B)(4) PASSED VISUAL INSPECTION, FUNCTIONAL CHECKS AND SYSTEM RUNNING TEST. NO ANOMALIES WERE OBSERVED DURING IN-HOUSE TESTING. EXAMINATION OF THE DOWNLOADED LOG FILES SHOWS THAT ON (B)(6) 2018, AT APPROXIMATELY 10:43:55 HRS. THE CONTROLLER LOST POWER. THIS WAS CAUSED BY A DOUBLE DISCONNECT OF BOTH POWER SOURCES, (B)(4) AT PS1 AND AC ADAPTER AT PS2. FIG1 SHOWS THESE EVENTS RATHER VISUALLY WHILE FIG2 IS A CHRONOLOGICAL ORDER OF THE LOG ENTRIES OF ALL THREE FILES TO SHOW THE FLOW OF EVENTS. NOTHING DURING LAB TESTING OR IN THE FILES INDICATE AN INTRINSIC MALFUNCTION OF THE CONTROLLER. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY. BATTERY / (B)(4) / MODEL #: 1650- / EXPIRATION DATE: 2018-06-30, UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-06-30. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CAC ADAPTOR. CAC ADAPTOR / N/A / MODEL #: 1425US / EXPIRATION DATE: N/A UDI #: N/A. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: N/A. (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 THE PATIENT WAS FOUND DOWN AT HOME. THE PATIENT WAS INTUBATED AND REMAINS UNRESPONSIVE. REVIEW OF LOG FILES INDICATED POWER SWITCHING AND LOSS OF POWER WHILE PLUGGING INTO A BATTERY AND CAC ADAPTOR. THE CONTROLLER WAS EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268635 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420-CONTROLLER 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R 1103 VAD