BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6277604 · Received January 25, 2017

    Report

    Report Number
    3007042319-2017-00248
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    January 4, 2017
    Report Date
    October 17, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES FOR THIS COMPLAINTS: (B)(4) - 1650DE - MFR. DATE: 12/31/2015 - EXP. DATE: 12/31/2016. (B)(4) - 1650DE - MFR. DATE: 12/31/2015 - EXP. DATE: 12/31/2016. (B)(4) - 1650DE - MFR. DATE: 12/31/2015 - EXP. DATE: 12/31/2016. (B)(4) - 1650DE - MFR. DATE: 12/31/2015 - EXP. DATE: 12/31/2016. (B)(4) - 1650DE - MFR. DATE: 12/31/2015 - EXP. DATE: 12/31/2016. (B)(4) - 1650DE - MFR. DATE: 12/31/2015 - EXP. DATE: 12/31/2016. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION 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. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    SERIAL: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL BATTERIES WERE EVALUATED BY THE MANUFACTURER. CORRECTION TO MFR DATE: (B)(4) / MFR DATE: 12-18-2015, (B)(4) / MFR DATE: 12-11-2015, (B)(4) / MFR DATE: 12-22-2015, (B)(4) / MFR DATE: 12-1102015, (B)(4) / MFR DATE: 12-21-2015, (B)(4) / MFR DATE: 12-22-2015. (B)(4). IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING EVENTS. THE CONTROLLER AND SIX BATTERIES WERE 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 CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. AN ATTEMPT WAS MADE TO REPLICATE THE ISSUE BY MANIPULATING THE BATTERY'S CONNECTION TO THE CONTROLLER DURING THE ANALYSIS OF THE UNIT. RESULTS REVEALED THAT THE ELECTRICAL CONNECTION BETWEEN THE BATTERIES AND THE CONTROLLER WAS STABLE. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4) CONTAINED THE SMR SOFTWARE. THE SOFTWARE UPGRADE CONTAINS A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). LOG FILE ANALYSIS ALSO REVEALED A PREMATURE POWER SWITCHING EVENT DUE TO A COMMUNICATION ERROR INVOLVING (B)(4). THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION, INVESTIGATING MOMENTARY DISCONNECTION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT HAS EXPERIENCED BATTERY SWITCHING FOR "A LONG TIME." THE SWITCHING OCCURRED SO OFTEN THAT THE PATIENT REPORTED "BEING SCARED." THE CONTROLLER AND SIX BATTERIES WERE EXCHANGED WITHOUT CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59263 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1