BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 14795562 · Received June 23, 2022

    Report

    Report Number
    3007042319-2022-05510
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 31, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707006897
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE BATTERY WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE BATTERY PASSED VISUAL INSPECTION. AS RECEIVED, THE BATTERY'S GAS GAUGE BUTTON DID NOT RESPOND WHEN IT WAS PRESSED; THE BATTERY GAS GAUGE DISPLAY LIGHT EMITTING DIODES (LEDS) WERE OFF. HOWEVER, FUNCTIONAL TESTING REVEALED THAT THE BATTERY WAS REPORTING A FROZEN RELATIVE STATE OF CHARGE (RSOC) VALUE OF 100% ON THE TEST EQUIPMENT. FURTHER TESTING REVEALED THE BATTERY WAS ALSO REPORTING ABNORMAL BATTERY PARAMETERS ON THE TEST EQUIPMENT. THESE OBSERVATIONS ARE INDICATIVE OF A FAULT OF THE INTEGRATED CIRCUIT (IC) THAT CONTROLS THE BATTERY. AN ATTEMPT TO RESET THE MAIN INTEGRATED CIRCUIT WAS ABLE TO REESTABLISH THE BATTERY'S FUNCTIONALITY, INCLUDING NORMAL FUNCTIONING OF THE BATTERY'S GAS GAUGE LEDS. CONTROLLER LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED POWER SWITCHING EVENT COULD NOT BE CONFIRMED. IT IS POSSIBLE THE OBSERVED FAULT IN THE MAIN IC COULD HAVE BEEN PERCEIVED AS THE REPORTED EVENT. THE BATTERY HAD BEEN LUBRICATED PRIOR TO RELEASE. APPLICABLE RISK DOCUMENTATION, EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES, AND THE AVAILABLE INFORMATION WERE CONSIDERED; POSSIBLE ROOT CAUSES OF THE REPORTED EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, A FAULTY BATTERY, COMMUNICATION ERROR, AND/OR MOMENTARY DISCONNECTIONS DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00519785, THE MOST LIKELY ROOT CAUSE OF THE OBSERVED BATTERY FROZEN RSOC VALUES AND ABNORMAL BATTERY PARAMETERS EVENT HAS BEEN ATTRIBUTED TO THE BATTERY CONNECTOR INTERFACE DESIGN WHICH DOES NOT GUARANTEE THE DESIRED CONNECTION ANGLE IN SOME USE CONDITIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY WAS POWER SWITCHING. THE BATTERY WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454081 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650 00888707006897

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male 1103 VAD