BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 7826785 · Received August 29, 2018

    Report

    Report Number
    3007042319-2018-04132
    Event Type
    Death
    Date Received
    August 29, 2018
    Date of Event
    August 23, 2018
    Report Date
    January 4, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL PATIENT DETAILS. THE PATIENT IS A PARTICIPANT IN THE VAD DESTINATION THERAPY POST APPROVAL STUDY. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. 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

    INITIAL MDR DATE MFR. REC: (B)(6) 2018, PRODUCT EVENT SUMMARY: THE PUMP, THE CONTROLLER AND TWO (2) BATTERIES WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2018, AT 15:41:11. THE DATA POINT RECORDED PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT ONE (1) WITH 47% RELATIVE STATE OF CHARGE (RSOC) AND NO POWER SOURCE WAS CONNECTED TO POWER PORT TWO (2). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT ONE (1) AND (B)(4) WAS CONNECTED TO POWER PORT TWO (2). THE CONTROLLER WAS WITHOUT POWER FOR A MAXIMUM OF 48 MINUTES AND 54 SECONDS. ADDITIONALLY, REVIEW OF THE CONTROLLER LOG FILES REVEALED FOUR (4) LOW FLOW ALARMS RECORDED SINCE (B)(6) 2018. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED 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, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. ADDITIONAL PRODUCTS: (B)(4). 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 · 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. OTHER DEVICES INVOLVED: BATTERY / (B)(4) / MODEL #1650DE / (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY / (B)(4) / MODEL #1650DE / (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. LABELED FOR SINGLE USE: NO. (B)(4). CONTROLLER / (B)(4) / MODEL #1407KR / (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. LABELED FOR SINGLE USE: NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: HVAD PUMP, THE CONTROLLER AND TWO (2) BATTERIES (B)(4) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2018, AT 15:41:11. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT ONE (1) WITH 47% RELATIVE STATE OF CHARGE (RSOC) AND (B)(4) WAS CONNECTED TO POWER PORT TWO (2). A MOMENTARY DISCONNECTION WAS RECORDED LEADING UP TO THE LOSS OF POWER. THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT (1) AND (B)(4) WAS CONNECTED TO POWER PORT TWO (2). THE MAXIMUM TIME THE CONTROLLER WAS WITHOUT POWER WAS FOR 48 MINUTES AND 54 SECONDS. ADDITIONALLY, REVIEW OF THE CONTROLLER LOG FILES REVEALED 4 LOW FLOW ALARMS RECORDED SINCE (B)(6) 2018. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON BOTH POWER SOURCES. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED 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, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. THERE ARE INTERNAL INVESTIGATIONS FOR MOMENTARY DISCONNECTIONS AND ONE TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. OTHER DEVICES INVOLVED: (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 WAS HOME ALONE AND EXPERIENCED A DOUBLE POWER DISCONNECT FOLLOWED BY A PUMP STOP. IT IS UNKNOWN WHAT CAUSED THE DOUBLE POWER DISCONNECTION. THE PATIENT WAS FOUND UNCONSCIOUS AND NOT BREATHING BY THE PATIENT CAREGIVER. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM AND CARDIOPULMONARY RESUSCITATION WAS STARTED ON THE PATIENT. CARDIOPULMONARY RESUSCITATION WAS STOPPED, AND THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU). A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED. THE FUNCTIONALITY OF THE PUMP REMAINED NORMAL BUT THERE WAS NO CARDIAC BEAT SEEN ON ECHOCARDIOGRAM. THE PATIENT¿S PUPIL REFLEX WAS FIXED, THE PATIENT WAS NOT BREATHING ON THEIR OWN AND THERE WAS NO NEUROLOGICAL REFLEX. THE PATIENT WAS PUT ON INTRAVENOUS INOTROPIC SUPPORT, AND EXPERIENCED LOW FLOWS. THE PATIENT DIED ON (B)(6) 2018. THE PUMP WAS STOPPED BY THE SITE WHICH LEAD TO CARDIAC ARREST AND HYPOXIC BRAIN DAMAGE. THE ESTIMATED PUMP OFF TIME BASED ON LOG FILES WAS APPROXIMATELY 33 MIN 59 SEC TO 48 MIN 59 SEC. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IMPLANTED. THE CUSTOMER NOTIFIED THE CONTROLLER AND TWO BATTERIES SHOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672072 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death