BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3021537 · Received March 26, 2013

    Report

    Report Number
    3007042319-2013-00044
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY HEARTWARE AND AN ANALYSIS IS ONGOING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. OF NOTE, THE CONTROLLERS WERE NOT INCLUDED AS PART OF THE COMPLAINT BY THE REPORTER NOR WERE THEY SENT BACK TO HEARTWARE FOR ANALYSIS. REPLACING THE CONTROLLER(S) WAS PART OF THE OVERALL TROUBLESHOOTING CONDUCTED BY THE SITE TO ATTEMPT TO DETERMINE THE CAUSE OF THE ISSUE. EVEN AFTER EXCHANGING THE CONTROLLER THERE WAS NO APPRECIABLE CHANGE IN PUMP PERFORMANCE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO HEARTWARE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF HVAD PUMP HW3520 IN RELATION TO THE REPORTED EVENT. THESE INCLUDED LABELING/INSTRUCTIONS FOR USE, CLINICAL EVALUATION, LOG ANALYSIS, VISUAL/FUNCTIONAL TESTING, REVIEW OF MANUFACTURING DOCUMENTATION AND PATHOLOGICAL ANALYSIS. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT HW3520 MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES CONFIRMED HIGH POWER CONSUMPTION WITH "HIGH WATTS" ALARMS RELEVANT TO THE REPORTED EVENT. INDEPENDENT PATHOLOGICAL EVALUATION OF THE RETURNED PUMP CONFIRMED THE PRESENCE OF THROMBUS WITHIN THE DEVICE. THE REPORTED EVENT OF HIGH POWER WAS CONFIRMED VIA REVIEW OF THE LOG FILES AND MOST LIKELY RELATES TO THE FIBRIN THROMBUS IDENTIFIED ON PATHOLOGICAL ANALYSIS. POST EXPLANT ENGINEERING EVALUATION DID NOT REVEAL ANY CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED EVENT OF HIGH POWER WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES AND IS LIKELY RELATED TO THROMBUS FOUND WITHIN THE PUMP ON PATHOLOGICAL ANALYSIS. THE ORIGIN OF THIS THROMBUS CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT THE THROMBUS WAS INGESTED FROM THE PATIENT'S NATIVE CIRCULATION DURING THE IMPLANT PROCEDURE. BASED ON REVIEW OF ALL OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT RELATES TO A DEVICE DEFECT.

    Additional Manufacturer Narrative · 1

    HEARTWARE IS SUBMITTING THIS CORRECTION TO A PREVIOUSLY SUBMITTED MDR REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED INCREASED PUMP PARAMETERS DURING HEARTWARE LVAD IMPLANTATION. THE PUMP WAS PREPPED AND PASSED THE PRE-IMPLANT WET TEST. THE PATIENT'S APEX WAS CORED USING THE HEARTWARE CORING TOOL. THE LV WAS INSPECTED FOR THROMBUS AND TRABECULAES, AND NO THROMBUS WAS NOTED. THE PUMP WAS PLACED AND WAS THEN STARTED WITH AN ESTIMATED FLOW OF 0.9 L/MIN WITH A POWER CONSUMPTION OF 2.4 WATTS (WITH THE OUTFLOW GRAFT STILL CLAMPED). WITHIN A FEW MINUTES THE PUMP'S ESTIMATED FLOW AND POWER CONSUMPTION BEGAN TO INCREASE CONTINUOUSLY. THE HVAD CONTROLLER DEMONSTRATED A HIGH PRIORITY ALARM THAT DISPLAYED THE MESSAGE: "VAD STOPPED/CHANGE CONTROLLER." THE HVAD CONTROLLER WAS REPLACED WITH THE BACK-UP CONTROLLER WHICH HAD PREVIOUSLY BEEN PROGRAMMED FOR THIS PATIENT. ACCORDING TO THIS CONTROLLER, THE SPEED WAS 420 RPM WITH POWER CONSUMPTION ON OVER 25 WATTS AND AN ESTIMATED FLOW OF OVER 10 L/MIN. THE SITE STOPPED THE PUMP AND THEN RE-STARTED THE PUMP WITH THE SAME CONTROLLER WITHOUT A CHANGE IN THE DISPLAYED PARAMETERS. THEY STOPPED THE PUMP YET AGAIN AND RE-STARTED AND THE DISPLAYED PARAMETERS REMAINED UNCHANGED. THE SPEED WAS THEN INCREASED FROM 1800 RPM TO 1900 RPM. THE MONITOR DISPLAYED THE CORRECT SPEED AND THE PUMP PARAMETERS BEGAN TO DECREASE. THE SPEED WAS INCREASED TO 2000 RPM WITH POWER CONSUMPTION OF 2.4 WATTS AND AN ESTIMATED FLOW OF 4 L/MIN. SINCE THE SURGEON WAS UNCLEAR ABOUT THE CAUSE OF THIS EVENT, HE/SHE OPTED TO REPLACE THE PUMP ((B)(4)) WITH ANOTHER HEARTWARE PUMP. UPON EXPLANTATION, THE INITIAL PUMP WAS VISUALLY INSPECTED AND NO ABNORMALITIES WERE SEEN FROM THE OUTSIDE. WHEN THE DEXTROSE FROM THE WET TEST FROM THE INITIAL PUMP WAS EXAMINED, PARTICLES WERE NOTED IN THE STERILE BOWL. THE NEW PUMP WAS SUCCESSFULLY WET-TESTED WITH NEW 5% DEXTROSE SOLUTION AT ROOM TEMPERATURE WITH PUMP PARAMETERS THAT INCLUDED A SPEED OF 1800 RPM AND POWER CONSUMPTION OF 1.2 WATTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123482 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR