BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 10050391 · Received May 13, 2020

    Report

    Report Number
    2916596-2020-02539
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    April 21, 2020
    Report Date
    August 7, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5, D11, H5, AND H8: CORRECTION . MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE COMMUNICATION FAULT ALARM WAS CONFIRMED VIA THE PROVIDED LOG FILE. THE LOG FILE CONTAINED DATA SPANNING 5 DAYS (B)(6) 2020 ¿ (B)(6) 2020, PER TIME STAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. A DRIVELINE COMMUNICATION FAULT ALARM BECAME ACTIVE ON (B)(6) 2020, AT 7:01, CORRELATING TO ¿COMMUNICATION LINE A.¿ THE ALARM REMAINED ACTIVE UNTIL THE PATIENT¿S DRIVELINE WAS OBSERVED TO BE DISCONNECTED AT 10:11 OF THE SAME DAY. NO OTHER NOTABLE EVENTS WERE OBSERVED. THE RETURNED MODULAR CABLE FAILED FUNCTIONAL TESTING DUE TO THE TEST REVEALING THAT ONE OF ITS CONDUCTORS WAS OPEN. THE CABLE WAS TESTED USING THE RETURNED SYSTEM CONTROLLER; HOWEVER, DRIVELINE COMMUNICATION FAULT ALARMS WERE NOT REPRODUCED EVEN WHEN THE CABLE WAS MANIPULATED. THE CABLE WAS DISASSEMBLED WHICH REVEALED THAT ITS GREEN WIRE WAS FRACTURED. THE GREEN WIRE IS RESPONSIBLE FOR COMMUNICATION LINE A. ALTHOUGH THE DRIVELINE COMMUNICATION FAULT ALARM WAS NOT REPRODUCED DURING TESTING, A DAMAGED GREEN WIRE WOULD CAUSE DRIVELINE COMMUNICATION FAULT ALARMS TO OCCUR. THE BROKEN WIRE APPEARS TO HAVE BEEN THE RESULT OF FATIGUE DAMAGE DUE TO REPETITIVE FLEXING OF THE CABLE. THE HEARTMATE 3 PATIENT HANDBOOK INSTRUCTS USERS ON HOW TO RESOLVED ALARMS THAT SOUND FROM THEIR SYSTEM CONTROLLER, INCLUDING DRIVELINE COMMUNICATION FAULT ALARMS. THE HEARTMATE 3 PATIENT HANDBOOK SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ AND SECTION 6 ¿CARING FOR THE EQUIPMENT¿ INSTRUCTS USERS TO REGULARLY INSPECT THEIR MODULAR CABLES FOR SIGNS OF DAMAGE AND TO OBTAIN A REPLACEMENT IF NEEDED. DAMAGE TO THE MODULAR CABLE MAY INTERRUPT PUMP OPERATION. THE HEARTMATE 3 PATIENT HANDBOOK SECTION TITLED "EMERGENCY CONTACT LIST" CAUTIONS 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.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2020-02541.

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE 3 LVAS IS (B)(4). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROFILE VORTEX BLUE FILE BROKE DURING USE. THE BROKEN PIECE COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517540 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HEARTMATE 3 SYSTEM CONTROLLER, (B)(4).