BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7523315 · Received May 17, 2018

    Report

    Report Number
    3007042319-2018-01975
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    April 24, 2018
    Report Date
    November 16, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: ONE CONTROLLER DC ADAPTER (B)(4) AND SIX BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. THE CONTROLLER (B)(4) WAS NOT AVAILABLE FOR ANALYSIS. ONE CONTROLLER AC ADAPTER (B)(4) WAS NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF CONTROLLER DC ADAPTER AND BATTERIES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER DC ADAPTER AND BATTERIES REVEALED THAT THE DEVICES 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 INVOLVING (B)(4). ADDITIONALLY, POWER SWITCHING DUE TO COMMUNICATION ERRORS WERE RECORDED INVOLVING (B)(4). AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. 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. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-12-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-12-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-12-31. UDI #: (B)(4). RETURN DATE: 2018-05-08. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-12-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-12-31. UDI #: (B)(4). RETURN DATE: 2018-05-08. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-12-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-12-31. UDI #: (B)(4). RETURN DATE: 2018-05-08. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-12-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-12-31. UDI #: (B)(4). RETURN DATE: 2018-05-08. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-12-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-12-31. UDI #: (B)(4). RETURN DATE: 2018-05-08. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-12-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER. CONTROLLER AC ADAPTER / (B)(4) / MODEL #: 1430DE / EXPIRATION DATE: UNKNOWN. UDI #: (B)(4). MFG DATE: UNKNOWN. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER DC ADAPTER. CONTROLLER DC ADAPTER / (B)(4) / MODEL #: 1440 / EXPIRATION DATE: UNKNOWN. UDI #: (B)(4). RETURN DATE: 2018-05-08. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POWER SWITCHING WITH THE CONTROLLER, SIX BATTERIES, A CONTROLLER AC ADAPTER, AND A CONTROLLER DC ADAPTER. THE BATTERY CAPACITY WAS GREATER THAN OR EQUAL TO TWENTY-FIVE PERCENT. THE CONTROLLER, SIX BATTERIES, CONTROLLER AC ADAPTER, AND CONTROLLER DC ADAPTER 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
    365360 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 1104 VAD