BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 16173343 · Received January 16, 2023

    Report

    Report Number
    2916596-2023-00278
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 16, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    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

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE COMMUNICATION FAULT ALARMS WAS CONFIRMED VIA LOG FILE ANALYSIS AND PRODUCT TESTING. THE HEARTMATE 3 MODULAR CABLE (LOT #: 7880077) WAS RETURNED FOR ANALYSIS, AND A LOG FILE SUBMITTED FOR REVIEW WAS DOWNLOADED FROM THE SYSTEM CONTROLLER (SERIAL #: (B)(4)). THE REVIEW OF THE EVENT LOG FILE SHOWED (B)(4) EVENTS SPANNING APPROXIMATELY 11 HOURS OF DATA (00:37:48 -10:37:36 ON (B)(6) 2022 PER TIMESTAMP). THROUGHOUT THE LOG FILE, THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT. THERE WERE DRIVELINE COMM FAULT ALARMS THROUGHOUT THE LOG FILE. BEGINNING FROM 00:37:05 TO 00:52:31, FROM 02:02:05 TO 02:02:12, AT 07:26:37, THEN FROM 08:23:34 TO 08:24:57, AND THEN FROM 10:20:51 TO 10:20:58, COM_A_FAULTS WERE INTERMITTENTLY ACTIVE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE PUMP OPERATION WAS NOT AFFECTED. THE HEARTMATE 3 VAD MODULAR CABLE (LOT #7880077) WAS RETURNED FOR ANALYSIS AND FUNCTIONALLY TESTED. THE MODULAR CABLE WAS FOUND NOT TO OPERATE AS INTENDED DURING THE EXAMINATION; THE DRIVELINE COMMUNICATION FAULT ALARM WAS REPRODUCED. THE CABLE'S INTERNAL CONDUCTORS WERE TESTED AND DID NOT PASS THE CONTINUITY TESTING DUE TO AN ELECTRICALLY OPEN CONNECTION WITHIN THE GREEN WIRE. THE UNDERLYING GREEN WIRE WAS COMPLETELY SEVERED. A ROOT CAUSE OF THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE DUE TO COM A; THE GREEN WIRE IS DAMAGED. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING DRIVELINE COMMUNICATION FAULT ALARMS. HEARTMATE 3 PATIENT HANDBOOK SECTION 4 - "LIVING WITH THE HEARTMATE 3" INSTRUCTS THE USER TO INSPECT THE MODULAR CABLE IN-LINE CONNECTOR FOR SIGNS OF DAMAGE, SUCH AS CRACKING, FRAYING, WEAR, EXPOSED WIRES, SHARP BENDS, OR KINKS. CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED). HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 2 - ¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK 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. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 - ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 - ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. THE HEARTMATE 3 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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 MODULAR CABLE (LOT#: 7880077) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE 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 ON (B)(6) 2022, THE PATIENT WENT TO THE CLINIC ON FOR A DRIVELINE COMMUNICATION FAULT ALARM. IT WAS NOTED BY TECHNICAL SERVICES THAT THE FAULT DID NOT INTERRUPT PUMP OPERATION OR ANY FEATURES OF THE SYSTEM BECAUSE THE REDUNDANT COMMUNICATION LINE WAS FUNCTIONING. THE MODULAR CABLE WAS EXCHANGED WITHOUT PROBLEMS AND THE ALARMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819108 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7880077 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male