BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 7912790 · Received September 26, 2018

    Report

    Report Number
    3007042319-2018-04569
    Event Type
    Malfunction
    Date Received
    September 26, 2018
    Date of Event
    September 24, 2018
    Report Date
    May 1, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE CONTROLLER AND TWO BATTERIES WERE RETURNED FOR EVALUATION. FAILURE ANALYSIS REVEALED THAT ALL THE RETURNED DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. SUPPLEMENTAL TESTING WAS PERFORMED ON THE CONTROLLER, AND THE TEST RESULTS REVEALED THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. THE EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT 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 PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4) WITHIN THE ANALYZED PERIOD. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON ALL ASSOCIATED DEVICES ON (B)(6) 2018. AS A RESULT, THE REPORTED PREMATURE POWER SWITCHING EVENT AFTER LUBRICATION WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT AFTER LUBRICATION CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO THE WEARING OF THE GOLD-PLATED PINS, EXPOSING THE PIN¿S BASE METAL TO THE EFFECTS OF CORROSION. OTHER DEVICES INVOLVED IN THIS EVENT: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: (B)(6) D10: YES, RETURN DATE: 2018-10-10 H3: YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 4307 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: CONTROLLER 2.0 / (B)(6) / MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 2018-10-31 UDI #: (B)(4) D10: YES, RETURN DATE: 2018-10-10 H3: YES H4: MFG DATE: 2017-10-31 H5: NO H6: DEVICE CODE(S): C133626 H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213, 174 H6: FDA CONCLUSION CODE(S): 4307 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.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE TWO BATTERIES WERE RETURNED. THE CONTROLLER WAS RETURNED AS WELL AS AN ASSOCIATED PRODUCT FOR THIS EVENT. THE CONTROLLER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    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. CONCOMITANT MEDICAL PRODUCTS: DDBB1D1 ICD, IMPLANTED ON (B)(6) 2016. 694765 LEAD, IMPLANTED ON (B)(6) 2012. 5076-52 LEAD, IMPLANTED ON (B)(6) 2012. OTHER DEVICES INVOLVED IN THIS EVENT: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BATTERY / (B)(4) / MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 01/31/2019, UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 01/24/2018, LABELED FOR SINGLE USE: NO, YES, IF PUMP. 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 POWER SWITCHING INVOLVING TWO BATTERIES. THE SITE REPORTED THAT BOTH THE BATTERIES WERE LUBRICATED ON (B)(6) 2018. THE BATTERIES ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749834 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1650 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 1103 - VAD