BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 20790919 · Received November 27, 2024

    Report

    Report Number
    2916596-2024-07514
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 6, 2024
    Report Date
    December 27, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MODULAR CABLE BEING EXCHANGED WAS CONFIRMED VIA THE PROVIDED INFORMATION, HOWEVER A REASON WHY THE MODULAR CABLE WAS EXCHANGED WAS UNABLE TO BE DETERMINED. DATA FROM THE REPORTED EVENT DATE OF 06NOV2024 IN THE DOWNLOADED CONTROLLER EVENT LOG FILE WAS REVIEWED. WHEN THE NEW DRIVELINE WAS FIRST CONNECTED ON 06NOV2024 AT 16:42:10, THE SPEED WAS 0 RPM. THIS IS CONSISTENT WITH THE MODULAR CABLE NOT BEING CONNECTED TO THE PUMP. ONCE THE PUMP WAS CONNECTED AT 17:06:18, THE PUMP SPEED OPERATED ABOVE THE LOW SPEED LIMIT. THE DRIVELINE WAS THEN DISCONNECTED AT 17:06:37 FOR A CONTROLLER EXCHANGE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE MODULAR CABLE, LOT NUMBER 7880077, WAS NOT RETURNED FOR ANALYSIS. THE PROVIDED INFORMATION STATED THAT THE PATIENT NEEDED A MODULAR CABLE EXCHANGE, SO THE BACKUP CONTROLLER WAS CONNECTED TO A NEW MODULAR CABLE AND BATTERIES. THE GREEN LIGHT DID NOT APPEAR LIT ON THE SYSTEM CONTROLLER TO INDICATE THE PUMP HAD STARTED. THE PATIENT LOST CONSCIOUSNESS AND WAS PLACED BACK ON THE ORIGINAL SYSTEM CONTROLLER AND ORIGINAL MODULAR CABLE. THE PATIENT WAS GIVEN A COMPLETELY NEW CONTROLLER AND REGAINED CONSCIOUSNESS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE REASON FOR EXCHANGE; HOWEVER, NO RESPONSE WAS RECEIVED. A ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. B) SECTION 2-¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 2-¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. THE HEARTMATE 3 LVAS PATIENT HANDBOOK (REV D) SECTION 10 ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE AND ENSURING THAT THE MODULAR IN-LINE CONNECTOR IS SECURE AND THE CONNECTOR LOCKING NUT IS IN THE LOCKED POSITION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT NEEDED THEIR MODULAR CABLE EXCHANGED. A NEW MODULAR CABLE WAS CONNECTED TO THEIR BACKUP SYSTEM CONTROLLER, WHICH HAD A NEW EMERGENCY BACKUP BATTERY (EBB), AND WAS CONNECTED TO 2 NEW 14V BATTERIES AND BATTERY CLIPS. THE GREEN LIGHT DID NOT APPEAR ON THE SYSTEM CONTROLLER TO INDICATE THE PUMP HAD STARTED. THE ALARM APPEARED AS A RED HEART, HOWEVER THERE WAS NOTHING ON THE SCREEN AND NO GREEN CIRCLE. THE PATIENT LOST CONSCIOUSNESS AND WAS PLACED BACK ON THE ORIGINAL SYSTEM CONTROLLER AND ORIGINAL MODULAR CABLE. THE PATIENT RETURNED TO THEIR BASELINE. WITH A NEW SYSTEM CONTROLLER, MODULAR CABLE, BATTERIES, AND BATTERY CLIPS, THE PATIENT LOST CONSCIOUSNESS FOR ABOUT 30 SECONDS. THE PATIENT GAINED CONSCIOUSNESS AS SOON AS THE NEW SYSTEM CONTROLLER INDICATED THE PUMP WAS RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360376 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7880077 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention