BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 8060678 · Received November 12, 2018

    Report

    Report Number
    3007042319-2018-05494
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    October 31, 2018
    Report Date
    March 1, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE BATTERY WAS NOT RETURNED FOR EVALUATION. THE LOG FILES OF THE CONTROLLER IN USE DURING THE REPORTED EVENT REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA LOGS REVEAL THAT THE BATTERY DISCHARGE AS EXPECTED WHEN IN USE. AS A RESULT, THE REPORTED BATTERY DISCHARGING ABNORMALLY COULD NOT BE CONFIRMED. A REVIEW OF THE ALARM FILE REVEALED THAT A POWER DISCONNECT ALARM WAS RECORDED ON (B)(6) 2018 INVOLVING THE BATTERY. THE LOGS RECORDED THAT THE BATTERY HAD EXPERIENCED A CELL UNDER VOLTAGE, PACK UNDER VOLTAGE AND CELL OVER VOLTAGE CONDITION. THE UNDER VOLTAGE CONDITION INDICATES THAT THE PACK AND A CELL PAIR DECREASED BELOW A PREDETERMINED VOLTAGE THRESHOLD, TRIGGERING A SAFETY FLAG. LIKEWISE, THE OVER VOLTAGE CONDITION INDICATES THAT A CELL PAIR WENT ABOVE A PREDETERMINE VOLTAGE THRESHOLD. THE SAFETY FLAGS LIKELY CAUSE THE BATTERY TO STOP PROVIDING POWER. AS A RESULT, THE REPORTED EVENT INVOLVING THE BATTERY FULLY DISCHARGING WAS CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO A COMMUNICATION ERROR, ASSEMBLY ERROR AND/OR DUE TO A BATTERY MALFUNCTION. 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 · 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 THE PATIENT'S BATTERY WAS DISCHARGING ABNORMALLY. THE BATTERY HAD THREE LIGHTS IN ITS CAPACITY DISPLAY, AND AFTER BEING DISCONNECTED AND RECONNECTED TWICE THE BATTERY WAS FULLY DISCHARGED. THE BATTERY WAS DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898445 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650DE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 1104 - VAD