BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5095051 · Received September 22, 2015

    Report

    Report Number
    3007042319-2015-02265
    Event Type
    Death
    Date Received
    September 22, 2015
    Date of Event
    September 13, 2015
    Report Date
    August 22, 2023
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LOG FILE ANALYSIS BY MANUFACTURER ENGINEER: LAST AVAILABLE DATA POINT WAS LOGGED ON (B)(6) 2015 WITH A SPEED OF 3000 RPM, POWER CONSUMPTION OF 6.5 W AND ESTIMATED FLOW OF 5.4 LPM. DATA POINT INDICATED THAT CONTROLLER WAS BEING POWERED BY BATTERY ON PORT 2 WITH ~55% CAPACITY AND BATTERY CONNECTED TO PORT 1 WITH ~96% CAPACITY. CONTROLLER LOST POWER BETWEEN 19:19 AND 19:27 (WHEN 1ST CONTROLLER POWER UP WAS LOGGED). A VAD STOPPED ALARM WAS LOGGED ON (B)(6) 2015 AT 19:29:44. ALARM CLEARED AFTER VAD DISCONNECT AT 19:30:54. 3 ADDITIONAL CONTROLLER POWER UPS WERE LOGGED AT THE FOLLOWING TIMES: 19:36:24 - VAD DISCONNECT ALARM WAS LOGGED AT 19:36:33; 19:38:24 - VAD DISCONNECT ALARM WAS LOGGED AT 19:38:32; 19:51:22. 7 ADDITIONAL VAD STOP ALARMS WERE LOGGED BETWEEN 19:43:46 AND 20:11:20 (CONTROLLER SUSPECTED TO BE CONNECTED TO THE MONITOR, AS 2 SPEED CHANGES WERE PERFORMED AT 19:56:32 AND 20:10:35). ADDITIONAL NOTE: START CURRENT AND START VMOT VALUES FOR ALL THE 2015 MOTOR STARTS WERE VERY HIGH. PREVIOUS MOTOR STARTS FROM 2011 TO MID-2014 HAVE MUCH LOWER CURRENT AND VOLTAGE VALUES. UNFORTUNATELY, WE DON'T HAVE ENOUGH DATA ABOUT WHAT LEVEL OF STARTING VOLTAGE MIGHT BE CONSIDERED DANGEROUS. 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. PER THE INSTRUCTIONS FOR USE (IFU): HIGH WATTS ALARMS, ARE AN INDICATION THAT THE PUMP WATTS HAS EXCEEDED THE HIGH POWER ALARM THRESHOLD, MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP, WHICH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE IFU ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED SUSPECTED PUMP THROMBUS; HOWEVER, IN ADDITION TO REQUIRED ADEQUATE ANTICOAGULATION, LVAD PUMP CANDIDATES OFTEN POSSESS SEVERAL RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED MOBILITY. IN ADDITION THE INSTRUCTIONS FOR USE (IFU) STATES: ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE VAD INCLUDE WARNING OF SERIOUS AND LIFE THREATENING ADVERSE EVENTS, SUCH AS DEATH. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    CHECKED OFF PRODUCT PROBLEM TO BETTER REFLECT EVENT. "THE PATIENT IS SAID TO BE STABLE NOW IN THE INTENSIVE CARE UNIT. IT WAS RECOMMENDED BY THE MANUFACTURER REPRESENTATIVE TO PERFORM AN "URGENT PUMP EXCHANGE." "PATIENT WAS PUT ON ECMO" (EXTRACORPOREAL MEMBRANE OXYGENATION) BUT PATIENT'S CONDITION DETERIORATED." "PATIENT DIED ON THE MORNING OF (B)(6) 2015". LOG FILE ANALYSIS; LAST AVAILABLE DATA POINT WAS LOGGED ON (B)(6) 2015 AT 19:19:31 WITH A SPEED OF 3000 RPM, POWER CONSUMPTION OF 6.5 W AND ESTIMATED FLOW OF 5.4 LPM. DATA POINT INDICATED THAT CONTROLLER WAS BEING POWERED BY PS2 ((B)(5) WITH ~55% CAPACITY) AND (B)(4) WAS CONNECTED TO PS1 WITH ~96% CAPACITY. A CONTROLLER POWER-UP EVENT WAS LOGGED ON (B)(6) 2015 AT 19:27:18, INDICATING A LOSS OF POWER TO THE CONTROLLER (B)(4) OF APPROXIMATELY 8 MINUTES. A VAD STOPPED ALARM WAS LOGGED ON (B)(6), 2015 AT 19:29:44. ALARM CLEARED AFTER THE VAD DISCONNECT ALARM AT 19:30:54. 3 ADDITIONAL CONTROLLER POWER-UP EVENTS INDICATING A LOSS OF POWER WERE LOGGED ON CONTROLLER (B)(4). IN ADDITION, 2 VAD DISCONNECT ALARMS AND 7 VAD STOPPED ALARMS HAVE BEEN LOGGED. IN CONCLUSION, THE POWER UP EVENTS WERE LINKED TO MULTIPLE VAD STOPPED ALARMS AND VAD DISCONNECT ALARMS INDICATING THAT THE PUMP WAS NOT ABLE TO RESTART ON CONTROLLER (B)(4). PATHOLOGY: GROSS FINDINGS ARE UNREMARKABLE; THERE IS NO GROSS EVIDENCE OF DEVICE COMPLICATION OR THROMBUS FORMATION. THE LVAD PUMP, TWO BATTERIES, AND TWO CONTROLLERS WERE RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT (B)(4) MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF DEVICES IN RELATION TO THE REPORTED EVENT. ANALYSIS OF THE CONTROLLERS REVEALED THAT THEY MET SPECIFICATIONS; BOTH CONTROLLERS PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4) PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING DUE TO A FAULTY CELL PAIR. THE FAULTY CELL COULD HAVE POTENTIALLY CONTRIBUTED TO THE INITIAL LOSS OF POWER TO THE CONTROLLER. HOWEVER, THE REPORTED EVENT COULD NOT BE REPLICATED AT BENCH LEVEL TESTING. ADDITIONALLY, FSCA DEC2015 WAS ISSUED TO RECALL ALL LISHEN CELL BATTERIES. (B)(4) PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING DUE TO AN INCIDENTAL FINDING OF A GAS GAUGE OUT OF CALIBRATION WHICH DID NOT CONTRIBUTE TO THE REPORTED EVENT. POWER SWITCHING EVENTS DUE TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES WERE OBSERVED BUT THIS IS AN INCIDENTAL FINDING AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. (B)(4) PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING BUT FAILED DIMENSIONAL VERIFICATION DUE TO REAR DISC CURVATURES OUT OF SPECIFICATION. HOWEVER, AS PER ETR00435, THESE DEVIATIONS ARE NOT EXPECTED TO IMPACT PUMP PERFORMANCE. LOG FILE ANALYSIS CONFIRMED A LOSS OF POWER OF APPROXIMATELY 8 MINUTES AS WELL AS VAD STOPPED ALARMS ON THE REPORTED EVENT DATE. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO FURTHER EVALUATE COMPLAINTS OF THIS NATURE WHEREIN THE PUMP FAILS TO RESTART AFTER MULTIPLE ATTEMPTS. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO PATIENT'S DEATH. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSE, OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION CONDUCTED, THE ROOT CAUSE FOR THE REPORTED FAILURE OF THE PUMP TO RESTART CANNOT BE CONCLUSIVELY DETERMINED. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 12-31-2014; NOTIFICATION RECALL NUMBER: Z-1607-2014. METHOD: ACTUAL DEVICE EVALUATED; ANALYSIS OF DATA LOG(S); RESULTS: NO FAILURE DETECTED; CONCLUSION: NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE 05-31-2015; NOTIFICATION RECALL NUMBER: Z-1607-2014. METHOD: ACTUAL DEVICE EVALUATED; ANALYSIS OF DATA LOG(S); RESULTS: ENERGY STORAGE SYSTEM PROBLEM; CONCLUSION: MANUFACTURING DEFICIENCY. (B)(4) - CONTROLLER / CATALOG NUMBER 1407DE / EXPIRATION DATE 12-31-2014; METHOD: ACTUAL DEVICE EVALUATED; ANALYSIS OF DATA LOG(S); RESULTS: NO FAILURE DETECTED; CONCLUSION: NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. (B)(4) - CONTROLLER / CATALOG NUMBER 1407DE / EXPIRATION DATE 12-31-2014; METHOD: ACTUAL DEVICE EVALUATED; ANALYSIS OF DATA LOG(S); RESULTS: NO FAILURE DETECTED; CONCLUSION: NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO ADDRESS THIS ISSUE. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL PROVIDE CLEAR INSTRUCTIONS TO THE USER ON PROPER USAGE AND CARE OF THE HVAD SYSTEM. MOREOVER, THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND HVAD SUPPORT; ADDITIONAL GUIDELINES INSTRUCT THE USER ON HOW TO DETECT AND REACT TO A 'VAD STOP'. A "VAD STOPPED" ALARM WILL ACTIVATE IF THE PUMP DRIVELINE IS NOT CONNECTED TO THE NEW CONTROLLER WITHIN 10 SECONDS. THIS ALARM WILL RESOLVE ONCE THE PUMP DRIVELINE IS CONNECTED. DEATH AS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. FURTHERMORE, THESE BENEFITS APPLY TO PATIENTS BEING BRIDGED TO HEART TRANSPLANT, PATIENTS RECEIVING PERMANENT SUPPORT (DESTINATION THERAPY), AND THOSE BEING SUPPORTED WITH THE EXPECTATION FOR MYOCARDIAL RECOVERY. 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 FROM THE (B)(4) ON 09/13/2015, THAT THE "VAD COORDINATOR CALLED TO REPORT A SUDDEN PUMP STOP." IT WAS STATED THAT THE "PATIENT WAS ADMITTED TO THE HOSPITAL, CONTROLLER EXCHANGED THREE TIMES WITH THREE DIFFERENT CONTROLLERS AND THE PUMP STILL DIDN'T RESTART." THE VAD COORDINATOR "SUSPECTED A CONNECTOR ISSUE" AND A SPLICE REPAIR WAS CONDUCTED WITH A PIECE OF NEW DRIVELINE AND A NEW CONNECTOR TO THE DRIVELINE." "AFTER CONNECTING THIS TO THE NEW CONTROLLER, THE PUMP SEEMED TO START, BUT REACHED 25 WATTS QUICKLY AND STOPPED AGAIN." VAD COORDINATOR "REATTEMPTED SPLICE REPAIR, WITHOUT AFFECT." IT WAS THOUGHT BY THE VAD COORDINATOR THAT THE "PUMP DID NOT START DESPITE THIS AS THE PUMP MAY BE FULLY CLOTTED NOW." "THE PATIENT IS SAID TO BE STABLE NOW IN THE INTENSIVE CARE UNIT. IT WAS RECOMMENDED BY THE MANUFACTURER REPRESENTATIVE TO PERFORM AN "URGENT PUMP EXCHANGE." "PATIENT WAS PUT ON ECMO" BUT PATIENT'S CONDITION DETERIORATED." "PATIENT DIED ON THE MORNING OF (B)(6) 2015". "LOG FILES WERE ANALYZED, REASON FOR PUMP STOP IS UNKNOWN AT THIS MOMENT." NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626240 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death