BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7655854 · Received July 2, 2018

    Report

    Report Number
    3007042319-2018-02815
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 11, 2018
    Report Date
    December 17, 2018
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE CONTROLLER WAS NOT RETURNED FOR EVALUATION. SIX BATTERIES 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 DEVICES REVEALED THAT (B)(4) PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF (B)(4) REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION. FUNCTIONAL TESTING REVEALED THAT TEST EQUIPMENT WAS UNABLE TO READ THE BATTERY STATUS. THE BATTERY WAS STILL ABLE TO CONNECT TO A CONTROLLER AND PROVIDE POWER. A SOFTWARE RESET WAS ABLE TO REESTABLISH COMMUNICATION WITH TEST EQUIPMENT. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT AND LIKELY DUE TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. A COMMUNICATION ERROR LIKELY UNINTENTIONALLY SEALED THE BATTERY. THE SEALED STATE DOES NOT IMPACT THE NORMAL OPERATION OF THE BATTERY; THE BATTERY WAS ABLE TO CHARGE AND PROVIDE POWER TO A CONTROLLER. CONTROLLER LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE SWITCHING EVENTS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTER IES. THE MOST LIKELY ROOT CAUSE OF BATTERY WITH A SEALED STATE CAN BE ATTRIBUTED TO COMMUNICATION ERRORS. (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 · 0

    THE CONTROLLER WAS NOT RETURNED FOR EVALUATION. SIX BATTERIES 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 DEVICES REVEALED THAT BAT221767, BAT222320, BAT221310, BAT222321, AND BAT222334 PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF BAT221315 REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION. FUNCTIONAL TESTING REVEALED THAT TEST EQUIPMENT WAS UNABLE TO READ THE BATTERY STATUS. THE BATTERY WAS STILL ABLE TO CONNECT TO A CONTROLLER AND PROVIDE POWER. A SOFTWARE RESET WAS ABLE TO REESTABLISH COMMUNICATION WITH TEST EQUIPMENT. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT AND LIKELY DUE TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. A COMMUNICATION ERROR LIKELY UNINTENTIONALLY SEALED THE BATTERY. THE SEALED STATE DOES NOT IMPACT THE NORMAL OPERATION OF THE BATTERY; THE BATTERY WAS ABLE TO CHARGE AND PROVIDE POWER TO A CONTROLLER. CONTROLLER LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE SWITCHING EVENTS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTER IES. THE MOST LIKELY ROOT CAUSE OF BATTERY WITH A SEALED STATE CAN BE ATTRIBUTED TO COMMUNICATION ERRORS. 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: 2017-08-31. UDI #: (B)(4). RETURN DATE: 2018-06-18. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-08-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31. UDI #: (B)(4). RETURN DATE: 2018-06-18. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-09-30. UDI #: (B)(4). RETURN DATE: 2018-06-18. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-09-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31. UDI #: (B)(4). RETURN DATE: 2018-06-18. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-09-30. UDI #: (B)(4). RETURN DATE: 2018-06-18. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-09-30. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-09-30. UDI #: (B)(4). RETURN DATE: 2018-06-18. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-09-30. (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 EXPERIENCING PREMATURE POWER SWITCHING ON MULTIPLE BATTERIES. THE CONTROLLER AND SIX 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
    498705 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420-CONTROLLER 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR MCS VAD