BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE II®, SYSTEM CONTROLLER

    MDR report key: 20828164 · Received December 2, 2024

    Report

    Report Number
    2916596-2024-07708
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 2, 2024
    Report Date
    January 10, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    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

    A4: PATIENT WEIGHT PROVIDED. D4: PRIMARY UDI NUMBER AND EXPIRATION DATE, UPDATED. H4: DEVICE MANUFACTURE DATE, UPDATED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENTS OF ATYPICAL LOW VOLTAGE ALARMS AND DAMAGE TO THE POWER CABLES WAS CONFIRMED. THE HEARTMATE II SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) WAS RETURNED FOR ANALYSIS, AND UPON INITIAL OBSERVATION, BOTH POWER CABLE¿S STRAIN RELIEFS WERE DAMAGED. A LOG FILE WAS DOWNLOADED AND SUBMITTED FOR REVIEW THAT SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 11 DAYS (02NOV2024 - 13NOV2024 PER TIMESTAMP). ATYPICAL LOW VOLTAGE ADVISORY ALARMS WHILE CONNECTED TO BATTERY POWER AND THE MOBILE POWER UNIT WERE ACTIVE THROUGHOUT THE LOG FILE DUE TO FLUCTUATING RSOC VOLTAGE READINGS ON BOTH POWER CABLES, WHICH WERE NOT COINCIDENT WITH POWER SOURCE EXCHANGES. THE ALARMS CLEARED SHORTLY AFTER ACTIVATING. PUMP OPERATION WAS NOT AFFECTED DURING THESE EVENTS. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2024 AT 12:28:20 FOR A SYSTEM CONTROLLER EXCHANGE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE SYSTEM CONTROLLER WAS CONNECTED TO A MOCK LOOP AND WAS ABLE TO SUPPORT THE SYSTEM FOR AN EXTENDED DURATION WITHOUT ISSUE. THE POWER CABLES OF THE SYSTEM CONTROLLER WERE MANIPULATED BY HAND, WHILE CONNECTED TO THE SYSTEM, WITHOUT ANY ALARMS ACTIVATING. THE ROOT CAUSE OF THE REPORTED EVENTS WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED (SHOP ORDERS # 187073, 189751, 191894) AND THE RECORDS REVEALED THE HEARTMATE II SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE II INSTRUCTIONS FOR USE SECTION 3 ENTITLED ¿POWERING THE SYSTEM¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 3 ENTITLED ¿POWERING THE SYSTEM¿ INSTRUCTS THE USER NOT TO BEND, TWIST, OR KINK THE POWER LEADS OF THE SYSTEM CONTROLLER AND ADDRESSES HOW LONG THE 14V BATTERIES PROVIDE POWER TO THE SYSTEM CONTROLLER. HEARTMATE II INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING LOW VOLTAGE ALARMS. HEARTMATE II INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A6: MISSING PATIENT INFORMATION IS PENDING FOLLOW-UP WITH HOSPITAL. D4: EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A LOT OF LOW VOLTAGE ADVISORIES, AND THE BLACK CABLE BATTERY WAS DRAINING FASTER THAN THE WHITE. THE POWER CABLES APPEARED SLIGHTLY WORN. LOG FILES WERE SENT FOR REVIEW TO ADVISE ON IF THE POWER CABLES WERE THE ISSUE. THE LOG FILE CONTAINED ABNORMALLY LOW VOLTAGE READINGS WHILE UTILIZING BOTH BATTERY AND MOBILE POWER UNIT (MPU)/POWER MODULE (PM) POWER. IT WAS RECOMMENDED TO REPLACE THE SYSTEM CONTROLLER IF THE PATIENT COULD TOLERATE THE EXCHANGE. THE SITE NOTED THAT THE CLIPS AND BATTERIES ALL APPEARED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266449 THORATEC® HEARTMATE II®, SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male