BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, EU

    MDR report key: 16668378 · Received April 3, 2023

    Report

    Report Number
    2916596-2023-01952
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 21, 2023
    Report Date
    May 22, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF AN UNEXPECTED NO EXTERNAL POWER ALARM WAS CONFIRMED WITH THE DATA RETRIEVED FROM THE RETURNED SYSTEM CONTROLLER (SERIAL # (B)(6)). THE LOG FILE CAPTURED UNEXPECTED NO EXTERNAL POWER (NEP) ALARM EVENTS WHEN THE WHITE POWER CABLE WAS DISCONNECTED DURING POWER EXCHANGES. THE NEP ALARM CONSISTENTLY BECAME ACTIVE EVEN WHEN THE BLACK POWER CABLE REMAINED CONNECTED. THE DEVICE WAS TESTED TOGETHER WITH LABORATORY EQUIPMENT AND WAS FOUND TO FUNCTION AS INTENDED. THE DEVICE PASSED THE FUNCTIONAL TEST PROCEDURE, CONFIRMING THAT ALL VISUAL AND AUDIBLE ALARMS ACTIVATED WHEN THEY WERE INDUCED. ELECTRICAL MEASUREMENT OF THE UNDERLYING WIRES WITHIN BOTH POWER CABLES DID NOT REVEAL ANY SHORTED OR CONDUCTOR BREAKDOWN CONDITION THAT COULD POTENTIALLY RELATED. AN UNEXPECTED NEP ALARM COULD NOT BE REPRODUCED DURING THE EVALUATION. ADDITIONAL INFORMATION COMMUNICATED THAT THE 11V BACKUP BATTERY ASSOCIATED WITH THE EVENT WAS EXCHANGED PRIOR TO RETURNING THE SYSTEM CONTROLLER. THE INFORMATION INDICATED THE BACKUP BATTERY WAS INSTALLED CORRECTLY. THE BACKUP BATTERY WILL NOT BE RETURNING FOR AN EVALUATION. A ROOT CAUSE OF THE UNEXPECTED NO EXTERNAL POWER ALARM EVENTS CAPTURED IN THE LOG FILE COULD NOT BE DETERMINED DURING THE EVALUATION. DEVICE HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO MFG AND QA SPECIFICATIONS. HEARTMATE II LVAS IFU DOC , HEARTMATE II PATIENT HANDBOOK(SECTION 5), UNDER ALARMS AND TROUBLESHOOTING, DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR. THIS INCLUDES ¿CONNECT POWER¿ ALARMS. 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). LOW BATTERY HAZARD ALARM 1. IMMEDIATELY CONNECT TO A WORKING POWER SOURCE (POWER MODULE OR TWO FULLY-CHARGED HEARTMATE 14 VOLT LITHIUM-ION BATTERIES). 2. IF ALARM PERSISTS, CALL YOUR HOSPITAL CONTACT IMMEDIATELY. LOW VOLTAGE ADVISORY ALARM 1. PROMPTLY CONNECT TO A WORKING OR DIFFERENT POWER SOURCE (POWER MODULE OR TWO FULLY-CHARGED HEARTMATE 14 VOLT LITHIUM-ION BATTERIES). 2. IF ALARM PERSISTS, CALL YOUR HOSPITAL CONTACT. POWER CABLE DISCONNECTED ALARM (¿CONNECT POWER¿ VISUAL MESSAGE), WHICH MEANS ONE OF THE SYSTEM CONTROLLER POWER CABLES IS DISCONNECTED FROM POWER. IF IT IS THE CABLE WITH THE BLACK CONNECTOR, THE TOP LIGHT COMES ON. IF IT IS THE CABLE WITH THE WHITE CONNECTOR, THE CENTER LIGHT COMES ON. IN SECTION 3, UNDER POWER THE SYSTEM, COVERS MAKING OR BREAKING CONNECTION BETWEEN POWER SOURCES. IN SECTION 8 OF HEARTMATE II LVAS IFU AND SECTION 6 OF HEARTMATE II PATIENT HANDBOOK OUTLINES HOW TO CARE FOR THE HEARTMATE 14 VOLT LITHIUM-ION BATTERIES AND BATTERY CLIPS HEARTMATE BATTERIES. ¿CLEAN THE METAL BATTERY CONTACTS AND THE INTERIOR CONTACTS OF BATTERY CLIPS MONTHLY USING A COTTON SWAB OR LINT-FREE CLOTH THAT HAS BEEN MOISTENED (NOT DRIPPING) WITH RUBBING ALCOHOL. ALLOW THE ALCOHOL TO DRY BEFORE USING NEWLY CLEANED BATTERIES OR CLIPS. DO NOT CLEAN BATTERIES WHILE THE BATTERIES ARE IN USE.¿ HEARTMATE II LVAS IFU HEARTMATE II PATIENT HANDBOOK, BOTH OF WHICH 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. 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

    IT WAS REPORTED THAT ON (B)(6) 2023 THE BACKUP BATTERY WAS IN USE EVERY TIME THE WHITE CABLE WAS DISCONNECTED. THE CONTROLLER WAS EXCHANGED ON (B)(6) 2023 AND THERE WERE NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059314 HEARTMATE II SYSTEM CONTROLLER, EU VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106017

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male