BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 8663171 · Received June 3, 2019

    Report

    Report Number
    3007042319-2019-07151
    Event Type
    Death
    Date Received
    June 3, 2019
    Date of Event
    May 22, 2019
    Report Date
    September 11, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: HVAD PUMP, TWO (2) CONTROLLERS, AND THE BATTERY WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT CONTAINS A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. LOG FILE ANALYSIS REVEALED A SUDDEN DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOW, FOLLOWED BY A SUDDEN INCREASE IN POWER CONSUMPTION AND ESTIMATED FLOW ON (B)(6) 2019. ONE (1) LOW FLOW ALARM AND EIGHT (8) HIGH WATT ALARMS WERE RECORDED ON (B)(6) 2019 BETWEEN 15:00:45 AND 17:39:22. A VAD DISCONNECT ALARM WAS RECORDED AT 18:55:08, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. AT 18:55:29, A VAD STOPPED ALARM WAS LOGGED INDICATING THAT THE MOTOR FAILED TO RESTART ON MULTIPLE ATTEMPTS, FOLLOWED BY MORE VAD STOPPED AND VAD DISCONNECT ALARMS. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILE REVEALED A POWER DISCONNECT ALARM WAS LOGGED INVOLVING A BATTERY AT 18:56:49. DURING THE POWER DISCONNECT ALA RM, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING AN OVERCURRENT ALERT. PRIOR TO THE POWER DISCONNECT ALARM WITH AN OVERCURRENT ALERT, A MOTOR START EVENT WAS RECORDED. THE EVENT LOG RECORDED A HIGH POWER CONSUMPTION DURING MOTOR START, WHICH REQUIRED MO RE CURRENT FROM THE BATTERY. THE BATTERY WAS MOST LIKELY PHYSICALLY DISCONNECTED BY THE PATIENT SHORTLY AFTER, CAUSING THE CONTROLLER TO LOG THIS EVENT AS A POWER DISCONNECT ALARM. LOG FILE ANALYSIS ALSO REVEALED THAT A VAD DISCONNECT ALARM WAS LOGGED ON (B)(6) 2019 AT 19:01:39 ON THE BACK UP CONTROLLER WHICH CORRESPONDS WITH THE REPORTED CONTROLLER EXCHANGE. AN ELECTRICAL FAULT ALARM WAS LOGGED AT 19:02:14 DUE TO THE REAR STATOR NOT BEING CONNECTED, FOLLOWED BY A VAD STOPPED ALARM AT 19:02:33 DUE TO OPEN PHASES ON BOTH STATORS. A SECOND ELECTRICAL FAULT ALARM WAS RECORDED AT 19:02:44 DUE TO THE REAR STATOR NOT BEING CONNECTED. AT 19:03:13, A VAD STOPPED ALARM WAS LOGGED INDICATING THAT THE MOTOR FAILED TO RESTART ON MULTIPLE ATTEMPTS, FOLLOWED BY MORE VAD STOPPED AND VAD DISCONNECT ALARMS. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, INAPPROPRIATE PUMP ROTATIONAL SPEED. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF THE REPORTED HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. THE MOST LIKELY ROOT CAUSE OF THE VAD DISCONNECT ALARM(S) CAN BE ATTRIBUTED TO A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. POSSIBLE ROOT CAUSES OF THE REPORTED ELECTRICAL FAULT ALARM(S) MAY BE ATTRIBUTED, BUT NOT LIMITED, TO A MARGINAL CONNECTION BETWEEN THE DRIVELINE AND CONTROLLER AND/OR CONTAMINATION OF THE CONNECTORS. A POSSIBLE ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARM MAY BE ATTRIBUTED, BUT NOT LIMITED, TO A PHYSICAL DIS CONNECTION OF THE POWER SOURCE. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE FOR THE FAILURE TO RESTART OF THE PUMP, RESULTING IN VAD STOPPED ALARMS, MAY BE ATTRIBUTED TO THE PRESENCE OF INCREASED STARTING RESISTANCE LIKELY DUE TO A THROMBUS INGESTION. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCTS: BRAND NAME : HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 SERIAL OR LOT#:(B)(4), PATIENT CODE(S): C28554, BRAND NAME : HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 ; SERIAL OR LOT#: (B)(4); PATIENT CODE(S): C28554 ; BRAND NAME : HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; SERIAL OR LOT#: (B)(4); PATIENT CODE(S): C28554 . MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED.

    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 AND DESTINATION THERAPY 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. CONCOMITANT MEDICAL PRODUCTS: 6935M62, LEAD, IMPLANTED: (B)(6) 2014. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-AUG-2019 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: NO. DEVICE EVAL BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 27-AUG-2018. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-JUL-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: NO. DEVICE EVAL BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 31-JUL-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-JAN-2019 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: NO. DEVICE EVAL BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 09-JAN-2018. LABELED FOR SINGLE USE: NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S VENTRICULAR ASSIST DEVICE (VAD) HAD HIGH WATT ALARMS. THE PATIENT WAS BROUGHT TO THE HOSPITAL WHERE THE PATIENT'S VAD STOPPED AND THE CONTROLLER HAD VAD STOP ALARMS. THE PRIMARY CONTROLLER WAS EXCHANGED TO THE BACKUP CONTROLLER BUT THE VAD STOP ALARM REMAINED UNRESOLVED. THE CONTROLLER WAS EXCHANGED BACK TO THE PRIMARY CONTROLLER. IT WAS FURTHER REPORTED THAT THE PATIENT HAD ELECTRICAL FAULT ALARM DUE TO A POSSIBLE PARTIAL DRIVELINE CONNECTION. ONE OF THE BATTERIES ALSO HAD A POWER DISCONNECT TRIGGERING A POWER DISCONNECT ALARM. THE PATIENT¿S VAD WAS TURNED OFF AND THE PATIENT WAS MOVED TO COMFORT CARE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455126 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death DVMB1D4 ICD