BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 15613007 · Received October 16, 2022

    Report

    Report Number
    2916596-2022-14201
    Event Type
    Malfunction
    Date Received
    October 16, 2022
    Date of Event
    September 25, 2022
    Report Date
    October 31, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL#: (B)(6)) WAS RETURNED FOR EVALUATION AFTER BEING EXCHANGED DUE TO LOW FLOW ALARMS. THE REPORTED EVENT OF LOW FLOW ALARMS WAS CONFIRMED. THE SYSTEM CONTROLLER (SERIAL #: (B)(6)) WAS RETURNED FOR ANALYSIS WITH THE 11V BACKUP BATTERY (SERIAL #: (B)(6)). A LOG FILE WAS EXTRACTED FROM THE SYSTEM DURING PRELIMINARY TESTING. A REVIEW OF THE EXTRACTED LOG FILE ((B)(6)) SHOWED 256 EVENTS SPANNING THREE DAYS (23SEP2022-26SEP2022 PER THE TIMESTAMP); ADDITIONAL EVENTS CAPTURED ON 10OCT2022 OCCURRED DURING PRELIMINARY TESTING OF THE RETURNED CONTROLLER. FROM 16:53:09 UNTIL 18:01:07 ON (B)(6)2022, THE LOG FILE CAPTURED MULTIPLE INTERMITTENT LOW FLOW (HAZARD) EVENTS ASSOCIATED WITH FLOW VALUE DROPPED TO 0 LPM; THESE EVENTS ARE ADDRESSED VIA THE PUMP INVESTIGATION (B)(6), PI-2022-0150371-01. THE DRIVELINE WAS DISCONNECTED ON 25SEP2022 AT 18:00:07 TO EXCHANGE THE SYSTEM CONTROLLER AT 18:01:07. IT WAS ALSO NOTED THAT BETWEEN 17:16:10 AND 17:56:24 ON (B)(6)2022, THE LOG FILE CAPTURED MULTIPLE PUMP SPEED MANIPULATIONS FROM 5300 RPM TO 5000 RPM, 4800 RPM, 5400 RPM, 5600 RPM, 3900 RPM, 4000 RPM, 3300 RPM, 3100 RPM, 3400 RPM, 3500 RPM, AND 5100 RPM. WHEN THE PUMP SPEED WAS SET BELOW THE LOW SPEED LIMIT (5000 RPM), THE CONTROLLER WAS ALARMED WITH A LOW SPEED ADVISORY ALARM, PER DESIGN. ALMOST 19 HOURS LATER, ON (B)(6)2022, FROM 13:33:49 TO 13:48:08, THE EXTERNAL POWER WAS RECONNECTED AND DISCONNECTED FROM THE SYSTEM CONTROLLER SEVERAL TIMES. PUMP SPEED AND LOW SPEED LIMIT SETTINGS WERE ADJUSTED FROM 5300 RPM TO 6500 RPM AND FROM 5000 RPM TO 6000 RPM, RESPECTIVELY. AT 13:47:20, THE DRIVELINE WAS RECONNECTED TO THE SYSTEM CONTROLLER, WITH THE SYSTEM OPERATING AT THE SET SPEED. AT 13:48:00, THE DRIVELINE WAS DISCONNECTED, THEN POWERED DOWN TO THE SYSTEM CONTROLLER AT 13:48:08. THE RETURNED SYSTEM CONTROLLER PASSED FUNCTIONAL TESTING USING LABORATORY TEST EQUIPMENT AND WAS ABLE TO SUPPORT A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY ISSUES. NO ATYPICAL ALARMS WERE REPRODUCED DURING TESTING, AND THE CONTROLLER WAS FOUND TO OPERATE A TEST PUMP AS INTENDED. THE INVESTIGATION DID NOT IDENTIFY A CORRELATION BETWEEN THE LOW FLOW ALARMS CAPTURED IN THE LOG FILE AND THE RETURNED SYSTEM CONTROLLER. THIS ANALYSIS DID NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE LOW FLOW ALARMS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS SHIPPED TO THE CUSTOMER ON 21DEC2018. THE HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, TABLE 12 INSTRUCTS USERS ON HOW TO IDENTIFY AND RESOLVE LOW FLOW ALARMS. THE HEARTMATE3 INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, TABLES 7.6 INSTRUCT USERS ON HOW TO INTERPRET AND TROUBLESHOOT LOW FLOW ALARMS. THE HEARTMATE3 PATIENT HANDBOOK CAUTIONS 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PUMP: MFR#2916596-2022-14200.

    Description of Event or Problem · 0

    THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224545 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531 6756174 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female