BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 21953236 · Received May 2, 2025

    Report

    Report Number
    2916596-2025-02536
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 3, 2025
    Report Date
    May 2, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER AND DRIVELINE DISCONNECT ALARM WAS CONFIRMED VIA LOG FILE ANALYSIS. DATA ON (B)(6) 2025 WAS REVIEWED. THE CONTROLLER EVENT LOG FILE REVEALED NO EXTERNAL POWER (NEP) ALARM EVENTS WERE CAPTURED ON 03APR2025 (AT 22:27:00) AND ON 07APR2025 (AT 22:06:12). PRIOR TO THE NEP ALARM EVENTS, ONE OF THE POWER CABLES WAS DISCONNECTED FROM 14V BATTERIES/CLIPS, WHICH ACTIVATED A POWER CABLE DISCONNECTED ALARM. THE NEXT EVENT CAPTURED THE NEP ALARM WHEN THE OTHER CABLE WAS DISCONNECTED. THE SYSTEM REVERTED TO THE INTERNAL 11V BACKUP BATTERY AND WAS UNAFFECTED BY THE LOSS OF POWER TO BOTH POWER CABLES. OF NOTE, A DRIVELINE DISCONNECT ALARM BECAME ACTIVE ON (B)(6) 2025 AT 22:40:40 WITH THE PUMP SPEED VALUE AT ZERO RPM AND ASSOCIATED HAZARD ALARMS (LOW FLOW, LVAD OFF). THE DRIVELINE APPEARED TO HAVE BEEN DISCONNECTED FOR APPROXIMATELY ELEVEN MINUTES. AT 22:51:19, THE DRIVELINE WAS CONNECTED; HOWEVER, DUE TO BOTH POWER CABLES BEING DISCONNECTED, THE PUMP DID NOT START. AT 22:51:50, BOTH POWER CABLES WERE CONNECTED TO THE MOBILE POWER UNIT AND THE SYSTEM BEGAN RAMPING UP WITH THE SPEED VALUE CAPTURED AT 5,200 RPM AT 22:51:55. ALL ALARMS CLEARED AT 22:52:00. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. SYSTEM CONTROLLER (SERIAL (B)(6) WAS UNAVAILABLE FOR EVALUATION. A ROOT CAUSE THAT LED TO THE NO EXTERNAL POWER AND DRIVELINE DISCONNECT ALARMS CAPTURED IN THE LOG FILE COULD NOT BE DETERMINED. DEVICE HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MFG AND QA SPECIFICATIONS. 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.¿ UNDER SECTION 5, ¿ALARMS AND TROUBLESHOOTING¿, ALL ALARM CONDITIONS ARE ADDRESSED. THIS INCLUDES ¿CONNECT POWER¿ AND DRIVELINE DISCONNECTED ALARMS. DRIVELINE DISCONNECTED ALARM. 1. IMMEDIATELY RECONNECT THE DRIVELINE TO THE SYSTEM CONTROLLER AND MOVE THE DRIVELINE SAFETY LOCK ON THE SYSTEM CONTROLLER TO THE LOCKED POSITION. ALSO, CHECK THAT THE MODULAR INLINE CONNECTOR IS SECURE. SEE PAGE 2-23. 2. IF ALARM PERSISTS AFTER RECONNECTING THE DRIVELINE, PRESS ANY BUTTON ON THE SYSTEM CONTROLLER TO ATTEMPT PUMP START. 3. IF THE ALARM STILL PERSISTS, CHECK IF THE FIXED SPEED SETTING IS BELOW 4000 RPM AND THE SYSTEM CONTROLLER¿S BACKUP BATTERY IS NOT INSTALLED. UNDER THESE CONDITIONS, THE PUMP CAN ONLY BE STARTED FROM THE SYSTEM MONITOR¿S CLINICAL OR SETTINGS SCREEN BY PRESSING THE PUMP START BUTTON. 4. IF DRIVELINE IS CONNECTED AND ALARM PERSISTS, REPLACE THE SYSTEM CONTROLLER WITH A CONFIGURED BACKUP SYSTEM CONTROLLER. LOW FLOW ALARM INDICATING FLOW IS LESS THAN 2.5 LPM. 1. ENSURE THAT THE DRIVELINE IS CONNECTED TO SYSTEM CONTROLLER. 2. ENSURE THAT A POWER SOURCE IS CONNECTED TO SYSTEM CONTROLLER. 3. CLINICALLY EVALUATE PATIENT. NO EXTERNAL POWER ALARM 1. IMMEDIATELY CONNECT THE SYSTEM CONTROLLER POWER CABLES TO A WORKING POWER SOURCE (FUNCTIONING MOBILE POWER UNIT OR TWO FULLY CHARGED HEARTMATE 14 VOLT LITHIUM-ION BATTERIES). 2. CALL YOUR HOSPITAL CONTACT IMMEDIATELY IF CONNECTING TO POWER DOES NOT RESOLVE THE ALARM. LOW POWER ALARM 1. PROMPTLY CONNECT TO A WORKING OR DIFFERENT POWER SOURCE (MOBILE POWER UNIT OR TWO HEARTMATE BATTERIES). 2. CALL YOUR HOSPITAL CONTACT IF CONNECTING TO POWER DOES NOT RESOLVE THE ALARM. POWER CABLE DISCONNECT ALARM 1. PROMPTLY CONNECT THE DISCONNECTED POWER CABLE TO A WORKING POWER SOURCE (MOBILE POWER UNIT OR TWO FULLY CHARGED HEARTMATE BATTERIES). 2. CALL YOUR HOSPITAL CONTACT IF RECONNECTING THE POWER CABLE DOES NOT RESOLVE THE ALARM. UNDER SECTION 3, ¿SWITCHING POWER SOURCES¿, DESCRIBES STEPS FOR EXCHANGING BETWEEN POWER SOURCES (MOBILE POWER UNIT AND BATTERIES). HEARTMATE 3 INSTRUCTIONS FOR USE UNDER SECTION F, SAFETY CHECKLISTS, REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. INSPECT ALL CABLES FOR SIGNS OF DAMAGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD SEVERAL NO EXTERNAL POWER ALARMS ON THE HISTORY OF THE SYSTEM CONTROLLER DATING BACK TO (B)(6) 2025. THERE WAS A 34 MINUTE NO EXTERNAL POWER ALARM FOLLOWED BY A DRIVELINE DISCONNECT ALARM AROUND 22:00 ON (B)(6) 2025. THE DRIVELINE APPEARED TO BE DISCONNECTED FOR 11 MINUTES. THE EVENT LOG FILE CAPTURED SEVERAL INSTANCES OF LOW VOLTAGE/NO EXTERNAL POWER WHILE USING THE MOBILE POWER UNIT (MPU). THESE OCCURRED ON (B)(6) 2025 AT 01:48, (B)(6) 2025 AT 23:00 AND AGAIN (B)(6) 2025 AT 23:01 AND 23:08. IT APPEARED THAT THE MPU LOST TOTAL POWER WHICH ENABLED THE EMERGENCY BACKUP BATTERY (EBB) IN THE SYSTEM CONTROLLER UNTIL POWER WAS RESTORED TO THE MPU. A COUPLE OF THESE INSTANCES LASTED A COUPLE MINUTES WITH NO INTERRUPTION IN PUMP SUPPORT. THERE WAS ALSO SOME NO EXTERNAL POWER EVENTS ON 03APR2025 AT 22:27 FROM WHAT APPEARED TO BE DISCONNECTING BOTH POWER LEADS WHEN CHANGING FROM BATTERY POWER TO THE MPU. ON (B)(6) 2025 AT 22:06, THERE WERE NO EXTERNAL POWER EVENTS NOTED FROM WHAT LOOKED LIKE BOTH POWER LEADS DISCONNECTED UNTIL 22:40 WHEN THE DRIVELINE SHOWED DISCONNECTED AS WELL. THE DRIVELINE RECONNECTED AT 22:51 AND RESUMED OPERATION. IT APPEARED THE VENTRICULAR ASSIST DEVICE WAS OFF FOR AROUND 11 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188708 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER Ventricular (assist) bypass DSQ THORATEC CORPORATION 106531US 8579089 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown