BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7805165 · Received August 22, 2018

    Report

    Report Number
    3007042319-2018-03987
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 5, 2018
    Report Date
    January 28, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE CONTROLLER, SIX BATTERIES AND ONE CONTROLLER AC ADAPTER WERE RETURNED FOR EVALUATION. FAILURE ANALYSIS REVEALED THAT THE RETURNED CONTROLLER, AC ADAPTER AND (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED (B)(4) REVEALED A TEAR ON THE OUTPUT CABLE. THE DAMAGE THAT WAS OBSERVED DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT AND LIKELY DUE TO WEAR AND/OR TO THE HANDLING OF THE DEVICE. LOG FILE ANALYSIS REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2018. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT ONE WITH 34% RELATIVE STATE OF CHARGE (RSOC) AND AN ADAPTER WAS CONNECTED TO POWER PORT TWO. THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT AND (B)(4) WAS CONNECTED TO POWER PORT TWO. THE CONTROLLER WAS WITHOUT POWER FOR 13 SECONDS. ANALYSIS OF DATA LOGS DID NOT REVEAL INSTANCES OF PREMATURE POWER SWITCHING EVENTS. AS A RESULT, THE REPORTED LOSS OF POWER WAS CONFIRMED; HOWEVER, THE REPORTED POWER SWITCHING COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE REPORTED DEVICES. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISC ONNECTION ON ONE OR BOTH POWER SOURCES. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE EVENTS INVOLVING THE CONTROLLER LOSING POWER AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRE ADDITIONAL PRODUCTS: (B)(4). 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 / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-05-31 UDI #: (B)(4), RETURN DATE: 2018-08-10, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-05-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-04-30 UDI #: (B)(4), RETURN DATE: 2018-08-10, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-04-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-03-31 UDI #: (B)(4), RETURN DATE: 2018-08-10, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-03-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30 UDI #: (B)(4), RETURN DATE: 2018-08-10, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-05-31 UDI #: (B)(4), RETURN DATE: 2018-08-10, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-05-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-05-31 UDI #: (B)(4), RETURN DATE: 2018-08-10, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-05-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CAC ADAPTER / (B)(4) / MODEL #: 1430DE, RETURN DATE: 2018-08-10, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN (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 EXPERIENCED MULTIPLE POWER SWITCHING EVENTS WHILE AT HOME. THE SITE FURTHER REPORTED THAT THE CONTROLLER MOMENTARILY LOSS POWER DURING ONE OF THE POWER SWITCHING EVENTS. ALL OF THE DEVICES HAVE BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647102 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 1104-VAD