BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 10504353 · Received September 8, 2020

    Report

    Report Number
    2916596-2020-04215
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 18, 2020
    Report Date
    April 20, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011255
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF AN EXPIRED BACKUP BATTERY WAS CONFIRMED. THE RETURNED BACKUP BATTERY, (B)(6) WAS EVALUATED. EVALUATION OF THE BATTERY INDICATED THAT THE BATTERY WAS LAST FULLY CHARGED ON 09APR2018 AND WAS NOT CHARGED EVERY 6 MONTHS OR WITHIN 24 MONTHS OF STORAGE. THUS, THE BATTERY FAILED SIMULATION OF SUPPORTING A SYSTEM FOR 15 MINUTES THROUGH AN ELECTRONIC LOAD. A ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE USER ERROR DUE TO FAILURE TO CHARGE THE BATTERY EVERY 6 MONTHS OR WITHIN 24 MONTHS OF STORAGE. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE 11V BATTERY WAS INSPECTED AND ACCEPTED INTO STORAGE LOCATION ON 23APR2018. (B)(6) WITH THE 11V BATTERY WAS SHIPPED TO THE CUSTOMER ON 28FEB2020. THE 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. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (DANISH) SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (DANISH) SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALARMS. HEARTMATE 3 IFU (DANISH) SECTION 2 ¿SYSTEM OPERATION¿ AND PATIENT HANDBOOK (DANISH) SECTION 2 - ¿HOW YOUR HEART PUMP WORKS¿ EXPLAINS THE USER OF HOW TO MAINTAIN THE BACKUP SYSTEM CONTROLLER¿S READINESS BY FULLY CHARGING THE BACKUP CONTROLLER¿S BACKUP BATTERY AND PERFORMING A SELF-TEST EVERY SIX MONTHS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE. PMA/510(K) #: P160054.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM CONTROLLER BACKUP BATTERY WAS NOT WORKING. THE BATTERY WAS EXCHANGED FOR A NEW ONE THAT WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967534 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106128 6535864 00813024011255

    Patients

    Seq Age Sex Outcome Treatment
    1