BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE II®, SYSTEM CONTROLLER

    MDR report key: 18057467 · Received November 2, 2023

    Report

    Report Number
    2916596-2023-07595
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    August 25, 2023
    Report Date
    May 23, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D3, G1: UPDATED INFORMATION. SECTION D1: CORRECTED. SECTION D4, CATALOG NUMBER: CORRECTED. SECTION D4, LOT NUMBER: CORRECTED. SECTION D4, PRIMARY UDI NUMBER: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE HEARTMATE II SYSTEM CONTROLLER (S/N: (B)(6) WAS EVALUATED FOLLOWING THE REPORTED EVENT OF A BACKUP BATTERY EXCHANGE. A REVIEW OF THE SUBMITTED LOG FILE (031708) CONTAINED 240 EVENTS SPANNING APPROXIMATELY 9 HOURS AND 46 MINUTES (5:27:37 - 15:13:42 (B)(6) 2023 PER TIMESTAMP). THE PUMP FIXED SPEED AND LOW SPEED LIMIT (LSL) WERE SET TO 9400 RPM AND 9000 RPM, RESPECTIVELY. THE PUMP MAINTAINED SPEEDS ABOVE THE LSL WITHOUT ISSUE WHILE CONNECTED TO THE DRIVELINE. ON 25AUG2023 AT 14:08:19, A NO EXTERNAL POWER AND LOW BATTERY HAZARD ALARM ACTIVATED DESPITE BOTH POWER CABLES REMAINING CONNECTED TO POWER. THE VOLTAGE VALUES WERE AT THE EXPECTED THRESHOLD. A BACKUP BATTERY FAULT, THAT DID NOT ACTIVATE AN ASSOCIATED ALARM, WAS ALSO ACTIVE AT THE TIME OF THE ALARMS. THE ALARMS SHORTLY RESOLVED ON THEIR OWN. AT 14:08:46, THE BACKUP BATTERY FAULT REMAINED ACTIVE DUE TO THE BACKUP BATTERY UNINSTALLED ALARMS (ERROR CODE 39), CONSISTENT WITH THE REPORTED BACKUP BATTERY EXCHANGE. THE ALARM QUICKLY RESOLVED. PUMP OPERATION WAS NOT AFFECTED. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. PER THE PROVIDED INFORMATION, THE BACKUP BATTERY WAS EXCHANGED DUE TO EXPIRING IN LESS THAN 6 MONTHS. THE REPORTED EVENT COULD NOT BE CORRELATED TO AN ISSUE WITH THE SYSTEM CONTROLLER. HEARTMATE II INSTRUCTIONS FOR USE, REV. C, SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II PATIENT HANDBOOK, REV. C, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING BACKUP BATTERY FAULT AND NO EXTERNAL POWER ALARMS. THE HEARTMATE II PATIENT HANDBOOK, REV. C, SECTION 10 ¿SAFETY CHECKLISTS, INSTRUCTS USERS TO REGULARLY INSPECT THEIR EQUIPMENT FOR DAMAGE, INCLUDING DAMAGE TO THE SYSTEM CONTROLLER¿S POWER CORDS, AND TO OBTAIN REPLACEMENTS IF NEEDED. 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. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE (QA) SPECIFICATIONS. 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 A BACKUP BATTERY (EBB) EXCHANGE DURING A CLINICAL VISIT ON (B)(6) 2023 AS IT WAS DUE TO EXPIRE IN LESS THAN 6 MONTHS. THE LOG FILE CONTAINED A BACKUP BATTERY FAULT POSSIBLY ASSOCIATED WITH THE EBB EXCHANGE ON 25AUG2023. THE ALARMS STOPPED AFTER THE BACKUP BATTERY WAS EXCHANGED. A FURTHER REVIEW OF THE LOG FILE REVEALED A NO EXTERNAL POWER AND A LOW BATTERY HAZARD ALARM ACTIVATED ON 25AUG2023 DESPITE BOTH POWER CABLES REMAINING CONNECTED TO POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009650 THORATEC® HEARTMATE II®, SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 202849 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male