BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 18426519 · Received January 2, 2024

    Report

    Report Number
    2916596-2023-08899
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 15, 2023
    Report Date
    June 4, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION B2: CORRECTED. SECTION D1: CORRECTED. SECTION D4: CORRECTED CATALOG NUMBER AND UDI. SECTION H6: CORRECTED MEDICAL DEVICE PROBLEM CODE. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE DISCONNECT AND PUMP STOP ALARMS CAN BE CONFIRMED BASED ON THE INFORMATION RECORDED IN THE PROVIDED LOG FILES FROM THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6) WHICH APPEARS TO BE THE PATIENT¿S PRIMARY CONTROLLER; HOWEVER, THE PROVIDED LOG FILES FROM THE SYSTEM CONTROLLER SERIAL NUMBER (B)(6) (PATIENTS BACKUP CONTROLLER) DID NOT CONTAIN ANY RECORDS ASSOCIATED WITH THE REPORTED EVENT. THE EVENT LOG FILE (CS-190377 MPEC-ADD-098992__C3E) DID NOT CONTAIN ANY DATA FROM THE REPORTED EVENT DATE. THERE WERE ENTRIES CAPTURED ON (B)(6) 2018 ASSOCIATED WITH THE MANUFACTURING PROCESS AND MULTIPLE ENTRIES CAPTURED BETWEEN (B)(6) 2019 AND (B)(6) 2023 WHERE THE CONTROLLER WAS BRIEFLY CONNECTED TO AN EXTERNAL POWER SOURCE FOR CHARGING. THE LAST THREE ENTRIES WERE CAPTURED ON (B)(6) 2023 AND THE DATA REVEALED THAT THE CONTROLLER¿S WHITE POWER CABLE WAS CONNECTED TO A POWER MODULE WHICH APPEARS CONSISTENT WITH THE PROCESS OF RETRIEVING THE LOG FILES. THERE WERE NO REPORTED ISSUES WITH THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6). PER THE PROVIDED ADDITIONAL INFORMATION, NO PRODUCT WILL BE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THE CONTROLLER WAS MANUFACTURED IN ACCORDANCE WITH MFG AND QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE REV C, UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN ALL ALARMS AND THE PROPER ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK CAUTIONS THE USERS TO ¿CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. YOUR HOSPITAL CONTACT CAN CHECK THE EQUIPMENT AND ORDER REPLACEMENTS, IF NEEDED. DO NOT TRY TO REPAIR ANYTHING YOURSELF.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EVENT LOG FILES WERE URGENTLY SUBMITTED FOR THE PATIENT WHO WAS FOUND DOWN AT HOME WITH DRIVELINE DISCONNECT ALARMS AND PUMP STOP ALARMS ON (B)(6) 2023. THE EVENT LOG FILES CAPTURED MULTIPLE DRIVELINE DISCONNECT EVENTS BEGINNING AT 3:07 PM ON (B)(6) 2023. THE EVENT LOG FILES ALSO CAPTURED BACKUP BATTERY (EBB) ALARMS BEGINNING AT 3:01 PM ON (B)(6) 2023. IT APPEARED THAT THE PATIENT SWAPPED TO THE BACKUP SYSTEM CONTROLLER AFTER THE EBB FAULT ALARMS. IT ALSO APPEARED THAT THE PATIENT CONNECTED BACK TO THE PRIMARY SYSTEM CONTROLLER A FEW MORE TIMES THAT DAY. THE EVENT LOG FILES FOR THE BACKUP SYSTEM CONTROLLER CAPTURED NO DATA. THE DRIVELINE WAS DISCONNECTED AND RECONNECTED IN THE EMERGENCY ROOM. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-08896 (HEARTMATE 3 PUMP (B)(4). RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-08898 (SYSTEM CONTROLLER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679727 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 6821240 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention