BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0

    MDR report key: 7602494 · Received June 14, 2018

    Report

    Report Number
    3007042319-2018-02482
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 19, 2018
    Report Date
    September 21, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE CONTROLLER AND 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. THE ALARM LOG FILE REVEALED SEVERAL POWER DISCONNECT ALARMS INVOLVING THE BATTERY. DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING A BATTERY CELL UNDER VOLTAGE. ANALYSIS OF THE ALARM LOG FILE ALSO REVEALED ONE CRITICAL BATTERY ALARM ON (B)(6) 2018 AT 00:25:54. THE DATA POINT PRIOR TO THE CRITICAL BATTERY ALARM, AT 00:15:07, REVEALED THAT THE BATTERY WAS AT 25% RELATIVE STATE OF CHARGE (RSOC). DURING THE CRITICAL BATTERY ALARM, DROPPED TO 0% RSOC. AS A RESULT, THE REPORTED POWER DISCONNECT ALARM AND CRITICAL BATTERY ALARM EVENTS WERE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE REP ORTED ALARMS ARE MOST LIKELY ATTRIBUTED TO A CELL-UNDER-VOLTAGE CONDITION, WHICH IS TRIGGERED WHEN A CELL PAIR FALLS BELOW A VOLTAGE THRESHOLD. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE CELL-UNDER-VOLTAGE CONDITION CAN BE ATTRIBUTED, BUT NOT LIMITED, TO A WELDING DEFECT, A FAULTY INTERNAL CELL PAIR, AND/OR A SOLDERING DEFECT. OTHER DEVICES INVOLVED IN THIS EVENT: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY SERIAL NUMBER: (B)(4). D4: MODEL 1650 EXPIRATION DATE: 2017-03-31 UDI: (B)(4). D10: NO H4: MFG DATE: 2016-03-31 H6 PATIENT CODES(S): C76143 H6 DEVICE CODE(S): C63030 H6 METHOD CODE(S): 4112, 4114 H6 RESULT CODE(S): 131 H6 CONCLUSION CODE(S): 4307 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.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT A BATTERY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THE BATTERY REMAINS IN USE.

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOG FILE REVIEW INDICATED TWO POWER DISCONNECT ALARMS ON THE CONTROLLER AND KNOWN CRITICAL BATTERY ISSUE DUE TO PATIENT NON-COMPLIANCE. IT WAS NOTED THAT THE PATIENT REMOVED BOTH POWER SOURCES FROM THE CONTROLLER. THE PATIENT WAS RETRAINED, AND THE CONTROLLER REMAINS 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
    444318 HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1