BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 8011547 · Received October 28, 2018

    Report

    Report Number
    3007042319-2018-05193
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Date of Event
    June 1, 2018
    Report Date
    April 10, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: SIX (6) BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF FIVE BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF ONE BATTERY REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION. FUNCTIONAL TESTING REVEALED A LIFTED CELL WELD BETWEEN CELL PAIRS, WHICH DID NOT ALLOW THE BATTERY TO PROPERLY CHARGE OR DISCHARGE. AS A RESULT, THE REPORTED POWER CONSUMPTION ISSUE WAS CONFIRMED. 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. REVIEW OF THE ALARM LOG FILES REVEALED SEVERAL POWER DISCONNECT ALARMS INVOLVING ONE BATTERY. DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING THAT A CELL PAIR DEPLETED BELOW A VOLTAGE THRESHOLD. AS A RESULT, THE REPORTED POWER DISCONNECT ALARMS WERE CONFIRMED. LOG FILE ANALYSIS DID NOT REVEAL ANY PREMATURE POWER SWITCHING EVENTS OR CRITICAL BATTERY ALARMS RECORDED WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED PREMATURE POWER SWITCHING POST LUBRICATION AND CRITICAL BATTERY ALARMS WERE NOT CONFIRMED. HOWEVER, LOG FILE ANALYSIS DID REVEAL MOMENTARY DISCONNECTIONS THAT DID NOT LEAD TO PREMATURE POWER SWITCHING INVOLVING BATTERIES FOUR BATTERIES. MOMENTARY DISCONNECTION WILL RESULT IN AN AUDIBLE TONE OR ¿BEEP¿. AS A RESULT, THE REPORTED ¿BEEPING¿ WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED ¿BEEPS¿ AFTER LUBRICATION CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO FRETTING CORROSION OF THE CONTROLLER POWER PORT PINS. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARMS AND POWER CONSUMPTION ISSUE CAN BE ATTRIBUTED TO A LIFTED CELL WELD.. ADDITIONAL PRODUCTS: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 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 NOTED THAT THE BATTERIES EXHIBITED CRITICAL BATTERY ALARMS WHILE POWER SWITCHING.

    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, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30, UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 2017-11-06, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30, UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 2017-11-06, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30 UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 2017-11-03, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30, UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 2017-11-05, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-11-30, UDI #: (B)(4), DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 2017-11-07, (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, AFTER LUBRICATION SERVICING, SIX VENTRICULAR ASSIST DEVICE (VAD) BATTERIES EXHIBITED POWER SWITCHING AND A RAPID DRAINING OF POWER. IT WAS ALSO REPORTED THAT MULTIPLE POWER DISCONNECT ALARMS OCCURRED DURING THE USE OF ONE OF THE BATTERIES. THE BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852176 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1650DE 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR (B)(4).