BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 7671306 · Received July 9, 2018

    Report

    Report Number
    3007042319-2018-02919
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    June 13, 2018
    Report Date
    December 4, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1698-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE SIX BATTERIES WERE RETURNED FOR EVALUATION. LOG FILE ANALYSIS WAS NOT PERFORMED SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT ALL DEVICES PASSED FUNCTIONAL TESTING. THE REPORTED EVENT COULD NOT BE DUPLICATED DURING BENCH TESTING. THE BATTERIES DID NOT EXPERIENCE POWER SWITCHING EVENTS AND WERE ABLE TO ADEQUATELY PROVIDE POWER TO A TEST CONTROLLER. HOWEVER, VISUAL INSPECTION OF (B)(4) REVEALED THAT THE BATTERY CONNECTORS WERE WORN OUT AND THE BATTERY CONNECTOR RELEASE INDICATORS WERE ILLEGIBLE. THESE ARE ADDITIONAL FINDING THAT ARE NOT RELATED TO THE REPORTED EVENT AND ARE LIKELY DUE TO WEAR AND/OR HANDLING OF THE DEVICES. 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 POWER SWITCHING EVENT CAN BE ATTRIBUTED TO COMMUNICATION ERRORS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE DAMAGED BATTERY CONNECTORS CAN BE ATTRIBUTED TO WEAR, LIKELY DUE TO NORMAL DISCONNECTION AND RECONNECTION BETWEEN THE BATTERY OUTPUT CABLE AND METAL POWER PORT CONNECTORS ON THE CONTROLLER. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE BENT/DAMAGED PINS WITH CONTROLLER 2.0 AND DAMAGED BATTERY CONNECTORS AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. (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

    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 / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-04-30 UDI #: (B)(4) MFG DATE: 2015-04-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-04-30 UDI #: (B)(4) MFG DATE: 2015-04-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-04-30 UDI #:(B)(4) MFG DATE: 2015-04-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-04-30 UDI #: (B)(4) MFG DATE: 2015-04-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-04-30 UDI #: (B)(4) MFG DATE: 2015-04-30 (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 EXPERIENCED POWER SWITCHING WHILE AT HOME. THE SITE FURTHER NOTED THAT THE CHARGE ON THE BATTERIES WERE GREATER THAN OR EQUAL TO TWENTY-FIVE PERCENT. THE DEVICES HAVE BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512275 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650DE 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 MCS UNKNOWN VAD