BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 10907398 · Received November 26, 2020

    Report

    Report Number
    2916596-2020-05632
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    October 1, 2015
    Report Date
    March 9, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO B5: PUMP EXCHANGE DUE TO DRIVELINE COMMUNICATION FAULT WILL NOT BE REPORTED IN THIS FILE. ONLY ONE PUMP EXCHANGE OCCURRED, AND IT IS REFERENCED IN MANUFACTURER'S REPORT NUMBER 2916596-2020-05635. THIS REPORT CAPTURES THE OTHER DRIVELINE COMMUNICATION FAULT THAT WAS NOTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED COMMUNICATION FAULT ALARM COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. FURTHERMORE, A SPECIFIC CAUSE FOR THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR A COMMUNICATION FAULT ALARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RESEARCH ABSTRACT EVALUATED 119 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (HM3 LVAD) PATIENTS, AND THE SPECIFIC DEVICE ASSOCIATED WITH THE EVENT WAS NOT REPORTED AND COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, ADDRESS ALL SYSTEM ALARMS, INCLUDING THE DRIVELINE COMMUNICATION FAULT, AS WELL AS THE RECOMMENDED ACTIONS ASSOCIATED WITH EACH. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE COMMUNICATION FAULTS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE OTHER INCIDENT IN THE STUDY THAT INVOLVED A DEVICE COMMUNICATION ALARM IS REPORTED IN MANUFACTURER'S REPORT NUMBER 2916596-2020-05635 SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN 01OCT2015 AND 30JUN2019. AUTHOR CITATION: FH SHEIKH ET AL. JOURNAL OF HEART AND LUNG TRANSPLANTATION, VOLUME: 39, ISSUE: 4, PAGES: S350. DOI: 10.1016/J.HEALUN.2020.01.406. MEDSTAR HEART AND VASCULAR INSTITUTE, MEDSTAR WASHINGTON HOSPITAL CENTER, WASHINGTON, DC, UNITED STATES. SERIAL NUMBER IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE RESEARCH ABSTRACT ¿ADMISSIONS DUE TO HEARTMATE 3 (HM3) ALARMS¿ IDENTIFYING THAT THE HEARTMATE 3 ALARMS LEAD TO READMISSION AND CAN REDUCE PATIENT QUALITY OF LIFE. THIS RETROSPECTIVE STUDY EVALUATED 119 HM3 PATIENTS IMPLANTED AT A SINGLE CENTER FROM 01OCT2015 TO 30JUN2019. CHARACTERISTICS OF HM3 PATIENTS ADMITTED WITH ALARMS WERE COMPARED TO HM3 PATIENTS NOT ADMITTED (NO ALARMS). THE ADMISSIONS WERE CATEGORIZED BASED ON THE CAUSE OF THE ALARM. A TOTAL OF 20 PATIENTS (17%) EXPERIENCED 46 ALARM ADMISSIONS, 44 WERE RELATED TO LOW FLOWS (LF), 2 WERE COMMUNICATION ALARMS, ONE OF WHICH REQUIRED PUMP EXCHANGE. PATIENTS WITH ALARMS WERE OLDER AND MORE LIKELY TO HAVE A HISTORY OF ATRIAL FIBRILLATION/FLUTTER. LEADING CAUSES FOR LF ALARMS WERE HYPERTENSION (33%), DEHYDRATION (24%), AND EQUIPMENT RELATED (15%). MEAN LENGTH OF STAY PER ADMISSION WAS 7.2±7 DAYS. SURVIVAL DID NOT DIFFER BETWEEN NO ALARM AND ALARM GROUPS (1-YEAR SURVIVAL, 85% VS 91%, P=0.64). THIS CASE IS REPORTING 1 PUMP EXCHANGE DUE TO DRIVELINE COMMUNICATION FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375248 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R