BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0

    MDR report key: 7285165 · Received February 21, 2018

    Report

    Report Number
    3007042319-2018-00715
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 23, 2018
    Report Date
    October 4, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 PRODUCT EVENT SUMMARY: THE CONTROLLERS (B)(4), BATTERIES (B)(4), AC ADAPTERS (B)(4), DC ADAPTER (B)(4), WAIST PACK (LOT NO. 1371861), AND BATTERY CHARGER (B)(4)WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE CONTROLLER LOG FILES COULD NOT BE PERFORMED SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED EVENTS COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH CRITICAL BATTERY ALARMS ARE MOST OFTEN ATTRIBUTED TO COMMUNICATION ERRORS OR THE BATTERY DEPLETING BELOW 10%. HOWEVER, THE REPORTED BEEPS ARE MOST LIKELY ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERY. ADDITIONAL PRODUCTS: BATTERY / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 CONTROLLER AC ADAPTER / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 CONTROLLER DC ADAPTER / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 WAIST PACK / 1371861 H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 BATTERY CHARGER / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 CONTROLLER 2.0 / (B)(4) / MODEL #: 1420 H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 CONTROLLER AC ADAPTER / (B)(4). H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4)/ MODEL #: 1650/ EXPIRATION DATE: 2018-10-31 UDI #: (B)(4), MFG DATE: 2017-10-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER, CONTROLLER AC ADAPTER / (B)(4)/ MODEL #: 1430US/ EXPIRATION DATE: UNKNOWN, UDI #: UNKNOWN, MFG DATE: UNKNOWN, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER DC ADAPTER, CONTROLLER DC ADAPTER / (B)(4)/ MODEL #: 1440/ EXPIRATION DATE: UNKNOWN, UDI #: UNKNOWN, MFG DATE: UNKNOWN, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ WAIST PACK, WAIST PACK / 1371861/ MODEL #: 2050US/ EXPIRATION DATE: 2018-11-30, UDI #: (B)(4), MFG DATE: 2017-11-30, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY CHARGER, BATTERY CHARGER / (B)(4)/ MODEL #: 1600US/ EXPIRATION DATE: UNKNOWN, UDI #: (B)(4), MFG DATE: UNKNOWN, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4)/ MODEL #: 1650/ EXPIRATION DATE: 2018-08-31, (B)(4), MFG DATE: 2017-08-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4)/ MODEL #: 1650/ EXPIRATION DATE: 2018-08-31, UDI #: (B)(4), MFG DATE: 2017-08-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4)/ MODEL #: 1650/ EXPIRATION DATE: 2018-11-30, UDI #: (B)(4), MFG DATE: 2017-11-30, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4)/ MODEL #: 1650/ EXPIRATION DATE: 2018-08-31, UDI #: (B)(4), MFG DATE: 2017-08-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, BATTERY / (B)(4)/ MODEL #: 1650/ EXPIRATION DATE: 2018-10-31, UDI #: UNKNOWN, (B)(4), MFG DATE: 2017-10-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER 2.0. BATTERY / (B)(4)/ MODEL #: 1650/ EXPIRATION DATE: 2018-10-31, UDI #: (B)(4), MFG DATE: 2017-10-310, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER, CONTROLLER AC ADAPTER / UNKNOWN/ MODEL #: 1430US/ EXPIRATION DATE: 2018-12-14, UDI #: (B)(4), MFG DATE: 2017-12-14, (B)(4). 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 PATIENT HAD PERSISTENT AUDIBLE BEEPS COMING FROM THE CONTROLLER. THERE WAS A HIGH PRIORITY CRITICAL BATTERY ALARM. INTERFERENCE WAS SUSPECTED. THE BATTERIES, CONTROLLERS, AC ADAPTERS, DC ADAPTER, WAIST PACK, AND BATTERY CHARGER WERE ALL EXCHANGED IN AN EFFORT TO DETERMINE IF ANY OF THE PRODUCTS WERE CAUSING INTERFERENCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130195 HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR (B)(4).