BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 10636933 · Received October 6, 2020

    Report

    Report Number
    3007042319-2020-05983
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    October 2, 2020
    Report Date
    January 15, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: FIVE (5) 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 BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. VISUAL INSPECTION AND VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED A DARK SUBSTANCE ON THE PINS WITHIN BATTERIES' CONNECTORS. HISTORICAL RESULTS FROM PREVIOUSLY TESTED SAMPLES REVEALED THAT THE SUBSTANCE IS CONSISTENT WITH THE LUBRICANT APPLIED AS A PART OF FSCA CVG-18-Q4-19. ADDITIONALLY, NO EVIDENCE OF DUST OR DIRT WAS OBSERVED. IT IS LIKELY THE LUBRICANT WAS PERCEIVED AS THE REPORTED ¿BATTERIES CONNECTOR PINS WERE DIRTY". LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT, CON312191, 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 FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6). AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON (B)(6) ON (B)(6) 2019. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING HAD BEEN PERFORMED ON (B)(6). THE MOST LIKELY ROOT CAUSE OF THE REPORTED "DIRTY" EVENT CAN BE ATTRIBUTED TO THE LUBRICANT PLACED ON POWER SOURCES UNDER FSCA CVG-18-Q4-19. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. CAPA PR00389403 INVESTIGATED MOMENTARY DISCONNECTIONS PRIOR TO LUBRICATION. ADDITIONAL PRODUCTS: (B)(6) D9:YES, RETURN DATE: 2020-10-13 H3: YES H6: PATIENT IME CODE(S): E2403 H6: IMF CODE(S): F26 H6: FDA METHOD CODE(S): B01,B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 (B)(6) D9:YES, RETURN DATE: 2020-10-13 H3: YES H6: PATIENT IME CODE(S): E2403 H6: IMF CODE(S): F26 H6: FDA METHOD CODE(S): B01,B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 (B)(6) D9:YES, RETURN DATE: 2020-10-13 H3: YES H6: PATIENT IME CODE(S): E2403 H6: IMF CODE(S): F26 H6: FDA METHOD CODE(S): B01,B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 (B)(6) D9:YES, RETURN DATE: 2020-10-13 H3: YES H6: PATIENT IME CODE(S): E2403 H6: IMF CODE(S): F26 H6: FDA METHOD CODE(S): B01,B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 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

    HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-08-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4); CONCOMITANT MEDICAL PRODUCTS/THERAPY DATES? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-08-2018. LABELED FOR SINGLE USE? NO. HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-08-2018 / SERIAL OR LOT#: (B)(4). UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/ THERAPY DATES? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-08-2018. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-08-2018 / SERIAL OR LOT#: (B)(4); UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/THERAPY DATES? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-08-2018. LABELED FOR SINGLE USE? NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM: BATTERY. MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-08-2018 / SERIAL OR LOT#: (B)(4); UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS/ THERAPY DATES? NO. DEVICE EVALUATED BY MFR? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-08-2018. 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 THE BATTERIES EXHIBIT POWER SWITCHING. THE BATTERIES CONNECTOR PINS WERE DIRTY. THE 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
    1100835 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1650DE 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN VAD| UNKNOWN VAD