BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 10631049 · Received October 5, 2020

    Report

    Report Number
    3007042319-2020-05968
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 12, 2020
    Report Date
    November 24, 2020
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000475
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. PRODUCT EVENT SUMMARY: ONE CONTROLLER AND ONE BATTERY WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. LOG FILE ANALYSIS REVEALED SEVEN CONTROLLER POWER UP EVENTS LOGGED ON 14-AUG-2020 AT 05:44:20, ON 22-AUG-2020 AT 20:43:26, ON 30-AUG-2020 AT 05:54:04, ON 01-SEP-2020 AT 05:50:14, ON 12-SEP-2020 AT 22:30:54, ON 16-SEP-2020 AT 20:51:14, AND ON 21-SEP-2020 AT 23:19:46. THE CONTROLLER WAS WITHOUT POWER FOR 10 SECONDS, 14 SECONDS, 8 SECONDS, 13 SECONDS, 17 SECONDS, 9 SECONDS, AND 7 SECONDS, RESPECTIVELY. SEVERAL MOMENTARY DISCONNECTIONS INVOLVING AN ASSOCIATED BATTERY WERE OBSERVED LEADING UP TO THE LOSS OF POWER ON 12-SEP-2020; THE EVENTS LEADING UP TO THE LOSS OF POWER ON 22-AUG-2020 COULD NOT BE CONFIRMED SINCE THE DATA LOG FILE DID NOT COVER THE ASSOCIATED DATE. REVIEW OF THE DATA LOG FILE AN INSTANCE INVOLVING (B)(6), WHERE THE RELATIVE STATE OF CHARGE (RSOC) VALUE WAS LOGGED BETWEEN 101-201, WHICH IS INDICATIVE OF A COMMUNICATION ERROR. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON THE BATTERY IN ACCORDANCE WITH THE REQUIREMENTS ON 17-JAN-2019. THE ASSOCIATED BATTERY WAS LUBRICATED PRIOR TO RELEASE. POSSIBLE ROOT CAUSES OF COMMUNICATION ERRORS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERIES, AND-OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. A POSSIBLE ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) H3: YES H6: PATIENT IME CODE(S): E2403 H6: IMF CODE(S): F26 H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 4307 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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

    CONCOMITANT MEDICAL PRODUCTS: DVFC3D4 ICD, IMPLANTED: (B)(6) 2018. 6935M62 LEAD, IMPLANTED: (B)(6) 2018. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 28-FEB-2019 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 28-FEB-2018. LABELED FOR SINGLE USE: NO. (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LOSSES OF POWER TO THE CONTROLLER AND THE BATTERY EXHIBITED A COMMUNICATION ERROR. THE CONTROLLER AND BATTERY WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095682 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000475

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 1103 VAD