BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 1.0

    MDR report key: 6240507 · Received January 11, 2017

    Report

    Report Number
    3007042319-2017-00088
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    April 14, 2016
    Report Date
    December 13, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT THE PATIENT'S CONTROLLER WAS SUCCESSFULLY EXCHANGED WITH NO REPORTED PATIENT CONSEQUENCE. THE EXCHANGE OF THE DEVICE IS REPORTED TO HAVE RESOLVED THE ISSUE. THE CONTROLLER WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE ADDED FOR THIS EVENT: (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL DATABASE INDICATES THAT THE HOSPICE NEVER RETURNED THE INVOLVED CONTROLLER(S) TO THE STUDY SITE. THE STUDY SITE WAS THEREFORE UNABLE TO CONFIRM WHETHER (B)(4) OR BOTH WERE INVOLVED IN THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 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 CONTROLLER IS A MICROPROCESSOR UNIT THAT CONTROLS AND MANAGES THE HEARTWARE SYSTEM OPERATION. IT SENDS POWER AND OPERATING SIGNALS TO THE BLOOD PUMP AND COLLECTS INFORMATION FROM THE PUMP. THE CONTROLLER'S INTERNAL, NON-REPLACEABLE, RECHARGEABLE BATTERY IS USED TO POWER AN AUDIBLE "NO POWER" ALARM WHEN BOTH POWER SOURCES ARE DISCONNECTED. THE INSTRUCTIONS FOR USE (IFU) WARNS USERS THAT A CONTROLLER WITH A BLANK DISPLAY OR NO AUDIBLE ALARMS SHOULD BE REPLACED. ACCORDING TO THE IFU, CONTROLLERS ARE EXPECTED TO FUNCTION FOR AT LEAST ONE YEAR. THE IFU AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. INABILITY TO READ THE DISPLAY ASSOCIATED WITH AN ALARM MAY RESULT IN NO ACTION OR THE WRONG OR INAPPROPRIATE ACTION TAKEN IN RESPONSE TO CRITICAL ALARMS. THE IFU AND PATIENT MANUAL FURTHER INSTRUCT USERS TO RETURN ANY DAMAGED COMPONENTS TO HEARTWARE. THE IFU CAUTIONS THE USER TO ALWAYS HAVE A BACKUP CONTROLLER AVAILABLE AND PROGRAMMED IDENTICALLY TO THE PRIMARY CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. PRODUCT HAS BEEN NOT RETURN.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED EVENTS OF DISPLAY WENT BLANK WITH NO SOUND AND BEEPS ALONG WITH BLINKING RED LIGHT. TWO CONTROLLERS (B)(4) WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH REPORTED BEEPS ARE MOST OFTEN ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. HOWEVER, THE DEVICES AND LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. (B)(4). 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

    A REPORT WAS RECEIVED FROM THE CLINICAL DATABASE THAT A PATIENT'S CONTROLLER EMITTED A "LIGHT BEEP LIKE A LOW BATTERY". THE PATIENT IS REPORTED TO HAVE BECOME SHORT OF BREATH AND WENT INTO RESPIRATORY FAILURE FOR TWO MINUTES ON (B)(6) 2016. THE SITE THEN REPORTED THAT THE DEVICE WENT BLANK WITHOUT ANY ALARMS GOING OFF. THIS IS REPORTED TO HAVE OCCURRED FOUR DIFFERENT TIMES OVER THE COURSE OF 24 HOURS. FROM THE REPORT, IT APPEARS THAT CONTROLLER WAS EXCHANGED BUT THIS COULD NOT BE VERIFIED. A PRELIMINARY SEARCH FOR CONTROLLER LOG FILES TO CLARIFY THE NATURE OF THE ALARMS AND WHETHER THE CONTROLLER WAS EXCHANGED WAS UNSUCCESSFUL. ON (B)(6) 2016, THE PATIENT'S CAREGIVER CALLED THE VAD COORDINATOR TO REPORT THE SAME ALARM "BLINKING RED LIGHT" THAT HAD OCCURRED THE PREVIOUS WEEK. WHEN ASKED TO SCROLL THROUGH THE ALARMS, THE CAREGIVER SAW NO ALARMS LOGGED. THE PATIENT'S CAREGIVER STATED THAT THE RED BLINKING ALARM WAS NOT SUSTAINED AND TURNED OFF BY ITSELF AFTER A SECOND OR TWO. THE SITE REPORTED THAT THE INVOLVED CONTROLLER(S) WERE NOT RETURNED TO THE SITE. THE PRIMARY INVESTIGATOR REPORTED THAT THIS EVENT WAS ASSOCIATED WITH THE VENTRICULAR ASSIST DEVICE (VAD) SYSTEM AND POSSIBLY RELATED TO THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25468 HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 1.0 CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other