BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 21550938 · Received March 7, 2025

    Report

    Report Number
    2916596-2025-01443
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    November 1, 2024
    Report Date
    March 27, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - REPORTER ESTABLISHMENT NAME: CORRECTION. G2 - REPORT SOURCE: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: REPORTS OF THE SYSTEM CONTROLLER BECOMING WARM TO THE TOUCH HAVE BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE INVESTIGATED AND MONITORED IF ADDITIONAL OCCURRENCES ARE REPORTED. NO LOG FILES WERE PROVIDED, AND NO PRODUCT WAS RETURNED UNDER THIS COMPLAINT AS THIS COMPLAINT DOES NOT PERTAIN TO A SPECIFIC EVENT. A SPECIFIC SYSTEM CONTROLLER SERIAL NUMBER IS NOT ASSOCIATED WITH THIS COMPLAINT. THE HEARTMATE 3 PATIENT HANDBOOK (REV. G, SECTION 2 ¿HOW YOUR PUMP WORKS¿) CAUTIONS "DO NOT PLACE THE SYSTEM CONTROLLER ON BARE SKIN FOR AN EXTENDED TIME. THE SYSTEM CONTROLLER SURFACE TEMPERATURE CAN BECOME UNCOMFORTABLY WARM, ESPECIALLY WHEN THE ROOM TEMPERATURE IS ABOVE 104°F (40°C)." THE HEARTMATE 3 PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT (SECTION TITLED ¿EMERGENCY CONTACT LIST¿). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS DEPLOYED AT TIME OF EVENT. HOUGH, R., DUNN, J. L., & HEPBURN, L. (2024). RE-IMAGINING THE FUTURE STATE OF THE VENTRICULAR ASSIST DEVICE CONTROLLER INTERFACE THROUGH HUMAN-CENTERED DESIGN. ARTIFICIAL ORGANS, 48(11), 1313-1345. DOI: HTTP://DX.DOI.ORG/10.1111/AOR.14817. SCHOOL OF ARCHITECTURE, DESIGN AND PLANNING, UNIVERSITY OF SYDNEY, SYDNEY, NSW, AUSTRALIA. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITERATURE ARTICLE ¿RE-IMAGINING THE FUTURE STATE OF THE VENTRICULAR ASSIST DEVICE CONTROLLER INTERFACE THROUGH HUMAN-CENTERED DESIGN¿ THAT THE HEARTMATE 3 (HM3) PUMP MAY BE ASSOCIATED WITH HEART ATTACKS, AND THE HM3 SYSTEM CONTROLLER MAY BE ASSOCIATED WITH OVERHEATING. IT WAS ALSO REPORTED THAT THE HM3 SYSTEM CONTROLLER MAY NEGATIVELY IMPACT PATIENTS¿ QUALITY OF LIFE, AS IT¿S FUNCTIONALITY CAN BE ASSOCIATED WITH PSYCHOLOGICAL SYMPTOMS. VENTRICULAR ASSIST DEVICE (VAD) PATIENTS (N = 21), CAREGIVERS (N = 4) AND HEALTHCARE PRACTITIONERS (N = 24) WERE INTERVIEWED TO UNCOVER DESIGN OPPORTUNITIES. FROM THIS, A SERIES OF REALISTIC SCENARIOS TO DESIGN FOR EMERGED. AN ADDITIONAL 15 PATIENTS AND 2 CAREGIVERS WERE ENGAGED TO EXPLORE CURRENT VAD SYSTEM CONTROLLER EXPERIENCES AND EVALUATE THE FUTURE-STATE CONCEPTS. AN ONLINE QUESTIONNAIRE ON THE PATIENT EXPERIENCE OF VAD WEARABLE EQUIPMENT WAS CONDUCTED WITH PARTICIPANTS RECRUITED FROM 15 ONLINE COMMUNITIES FOR VAD USERS WITH GLOBAL REACH, AND 65 VAD PATIENTS WHO HAD PARTICIPATED IN THE ONLINE QUESTIONNAIRE AND CONSENTED TO FOLLOW-UP RESEARCH WERE INVITED BY EMAIL TO STAGE 2 INTERVIEWS. IN THE INTERVIEWS, THERE WERE 17 PARTICIPANTS FROM UNITED STATES (N = 13), THE NETHERLANDS (N = 3), AND THE UNITED KINGDOM (UK) (N = 1). OF THIS GROUP, 14 PARTICIPANTS WERE CURRENT VAD PATIENTS (NINE MALES, FIVE FEMALES), ONE PARTICIPANT WAS A FORMER VAD PATIENT (ONE FEMALE POST-HEART TRANSPLANTATION FROM HEARTMATE II), AND TWO PARTICIPANTS WERE CURRENT CAREGIVERS TO A VAD PATIENT WHO WERE PRESENT IN THE INTERVIEWS WITH VAD PATIENTS (ONE MALE, ONE FEMALE). FOUR PATIENTS HAD BEEN IMPLANTED WITH A HEARTMATE II DEVICE, EIGHT PATIENTS HAD A HEARTMATE 3 DEVICE, AND THREE HAD RECEIVED A HEARTWARE HVAD. WHEN ASKED ABOUT THEIR EMOTIONAL EXPERIENCE, ONE PATIENT STATED THAT THE SYSTEM CONTROLLER WAS ¿TOO WARM, I MEAN, IT RADIATES HEAT YOU KNOW, 24/7. THAT'S BOTHERSOME.¿ ONE PATIENT EXPLAINED THAT THEY WANTED EMERGENCY CONTACTS TO BE NOTIFIED WITH CRITICAL OR NON-CRITICAL ALERTS BECAUSE THEY HAD ¿I'D DONE A HAT-TRICK WITH MY HEART ATTACKS. BECAUSE I'VE HAD A COUPLE.¿ THE FOLLOWING WERE REPORTED RELATED TO THE CURRENT STATE OF THE VAD PATIENT¿S EMOTIONS: PANIC (N = 7), IRRITATION (N = 3), OVERWHELMED (N = 3), ANXIETY (N = 4), CONCERN (N = 6), WORRY (N = 6), HATE (N = 3), AND MILD IRRITATION (N = 5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863199 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531INT 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown