BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3198133 · Received June 25, 2013

    Report

    Report Number
    2916596-2013-00803
    Event Type
    Death
    Date Received
    June 25, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING EQUIPMENT FROM THE PT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS: LVAD PUMP; SYSTEM CONTROLLERS; SERIAL#S (B)(4); 14 VOLT LITHIUM ION BATTERIES (QTY. (B)(4)) AND 14 VOLT LITHIUM ION BATTERY CLIPS (QTY. (B)(4)). LVAD PUMP: EXAMINATION OF THE RETURNED PUMP DID NOT REVEAL ANY ANOMALIES OR DEPOSITIONS ON THE SMOOTH OR TEXTURED BLOOD-CONTACTING SURFACES THAT WOULD HAVE AFFECTED PUMP FUNCTION. THE PUMP BEARINGS, ROTOR AND BLOOD CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. THE PERCUTANEOUS LEAD WAS RETURNED SEVERED APPROX 8" FROM THE PUMP HOUSING AND THE SEVERED PORTION OF LEAD WAS RETURNED IN TWO PIECES. THE RETURNED SECTIONS OF LEAD WERE ALL TESTED FOR CONTINUITY AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. NO WIRE-TO-WIRE OR WIRE-TO-SHIELD SHORTS WERE INDUCED DURING TESTING. THE EXTERIOR OF THE METAL/CONTROLLER CONNECTOR REVEALED SIGNIFICANT DAMAGE THAT WAS CONSISTENT WITH THE REPORT THAT A TOOL WAS USED IN ATTEMPT TO REMOVE THE PERCUTANEOUS LEAD FROM THE SYSTEM CONTROLLER. THE PINS OF THE CONNECTOR WERE NOT DAMAGED AND THE CONNECTION WAS MADE TO A TEST SYSTEM CONTROLLER WITHOUT ANY ISSUE. THE PUMP WAS CLEANED, REASSEMBLED AND FUNCTIONALLY TESTED UNDER VARIOUS LOADED CONDITIONS ACCORDING TO OUR MANUFACTURING PROCEDURE USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES. COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS AND THE PUMP OPERATED AS INTENDED. SYSTEM CONTROLLER, SERIAL# (B)(4): THE RETURNED SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED USING THE EQUIPMENT IN OUR LABORATORY AND WAS FOUND TO FUNCTION AS INTENDED. SYSTEM CONTROLLER, SERIAL# (B)(4): THE EVAL OF SYSTEM CONTROLLER REVEALED THAT THE PERCUTANEOUS LEAD GUARD AND THE C-RING INSIDE THE CONNECTOR WERE BROKEN. THE PERCUTANEOUS LEAD CONNECTOR WAS ALSO ROTATED WHICH AFFECTED THE PROPER ORIENTATION OF THE PERCUTANEOUS LEAD WHEN CONNECTING TO THE SYSTEM CONTROLLER. A REVIEW OF THE LOG FILE DOWNLOADED FROM THE SYSTEM CONTROLLER REVEALED APPROX 16 DAYS AND 14 HOURS OF EVENTS DURING WHICH TIME POWER CABLE DISCONNECT AND LOW VOLTAGE ADVISORY ALARMS WERE RECORDED. THE VOLTAGE LEVELS RECORDED AT THE TIME STAMP OF DAY 438, 22 HOURS AND 55 MINUTES SUGGEST THAT THE SYSTEM CONTROLLER WAS CONNECTED TO THE 14 VOLT LITHIUM ION BATTERIES. APPROX 12 HOURS AND 40 MINUTES LATER THERE WAS A LOW VOLTAGE ADVISORY ALARM RECORDED. THE INFO CONTAINED IN THE NEXT TWO ENTRIES OF THE LOG FILE REVEALED THAT THE BATTERIES WERE EXCHANGED WITH NEW BATTERIES. THE ASSOCIATED VOLTAGE LEVELS INDICATED THAT THE SYSTEM CONTROLLER WAS CONNECTED TO BATTERIES THAT WERE NOT FULLY CHARGED AND 51 MINUTES LATER THE LOW VOLTAGE ADVISORY ALARM BECAME ACTIVE FOLLOWED BY A LOW VOLTAGE HAZARD ALARM. THE NEXT RECORDED ENTRY AT DAY 439, 12 HOURS AND 27 MINUTES REVEALED THAT IN ADDITION TO THE ALARMS MENTIONED ABOVE, THERE WAS A POWER CABLE DISCONNECT ALARM FOLLOWED BY A POWER INTERRUPTION, WHICH WAS EVIDENCED BY A TIME STAMP RESET TO 0 DAYS, 0 HOURS AND 0 MINUTES. AFTER THE POWER WAS RESTORED TO THE SYSTEM CONTROLLER, THERE WERE PUMP DISCONNECTED AND MOTOR STOPPED ALARMED RECORDED. FOURTEEN VOLT LITHIUM ION BATTERIES (QTY. (B)(4)): (B)(4) 14 VOLT LITHIUM ION BATTERIES (BATTERIES) WAS RECEIVED FOR ANALYSIS. (B)(4) BATTERIES REQUIRED CALIBRATION WHEN RECEIVED AND (B)(4) BATTERIES WERE EXPIRED (MORE THAN 360 CYCLES AND MORE THAN 3 YEARS SINCE THE BATTERY MANUFACTURE DATE). THE BATTERIES THAT REQUIRED CALIBRATION WERE SUCCESSFULLY CALIBRATED AND THEN ALL BATTERIES WERE FULLY CHARGED AND DISCHARGED SEVERAL TIMES WITH NO ISSUES. ALL BATTERIES WERE PLACED INTO THE RETURNED 14 V LI-ION BATTERY CLIPS AND FUNCTIONALLY TESTED WHILE CONNECTED TO THE RETURNED SYSTEM CONTROLLER SERIAL # (B)(4) AND A TEST MOCK CIRCULATORY LOOP. THE SYSTEM FUNCTIONED AS INTENDED WITH NO ALARMS ACTIVE. FOURTEEN VOLT LITHIUM ION BATTERY CLIPS (QTY. (B)(4)): THE BATTERY CLIPS WERE FUNCTIONALLY TESTED AND OPERATED AS INTENDED. IN SUMMARY, BASED ON THE ANALYSIS OF THE RETURNED DEVICES AND EVAL OF THE PUMP DATA CAPTURED IN THE LOG FILE OF SYSTEM CONTROLLER SERIAL # (B)(4), IT APPEARS THE CAUSE FOR THE REPORTED RED HEART ALARM AND PT FEELING LIGHT-HEADED WAS DUE TO A LOW VOLTAGE CONDITION. A LOSS OF POWER TO THE SYSTEM LIKELY OCCURRED DURING THE ATTEMPT TO USE EXPIRED AND/OR UN-CALIBRATED BATTERIES. A REVIEW OF DEVICE HISTORY RECORDS FOR THE RETURNED DEVICES SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. THE USER FACILITY REPORT (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED THAT THE PT EXPIRED AFTER APPROX 1 YEAR AND 3 MONTHS OF SUPPORT. ACCORDING TO THE INFO PROVIDED TO THE MANUFACTURER, THE PT WAS AT HOME WHEN SHE EXPERIENCED A RED HEART ALARM AND FELT LIGHT-HEADED. THE PT'S HUSBAND REPORTEDLY ATTEMPTED TO REPLACE THE SYSTEM CONTROLLER BUT WAS HAVING DIFFICULTY AND A TOOL WAS USED TO ATTEMPT TO REMOVE THE PERCUTANEOUS LEAD. THE PT BECAME UNRESPONSIVE AND WAS TRANSPORTED TO THE HOSPITAL. IT WAS REPORTED THAT DURING THE REMOVAL OF THE PUMP, THE PERCUTANEOUS LEAD WAS CUT 3 DIFFERENT AREAS AND AN AREA OF SLIGHT WEAR WAS NOTED NEAR THE END OF THE VELOUR PORTION AT THE EXIT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289074 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111845

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death