BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17035685 · Received May 31, 2023

    Report

    Report Number
    2916596-2023-02845
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    April 22, 2023
    Report Date
    June 21, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENTAL FINDINGS: WIRE FATIGUE ON YELLOW AND ORANGE CONDUCTORS THAT DID NOT CONTRIBUTE TO THE REPRODUCED ALARMS/LOG FILE FINDINGS. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE COMMUNICATION FAULT ALARM WAS CONFIRMED. THE PROVIDED EVENT LOG FILE, AS WELL AS A LOG FILE EXTRACTED FROM THE RETURNED SYSTEM CONTROLLER WERE REVIEWED, COLLECTIVELY CONTAINING DATA SPANNING APPROXIMATELY 12 HOURS (23APR2023 AT 23:24 ¿ 24APR2023 AT 7:54 PER TIMESTAMP AND 24APR2023, 8:26 ¿ 11:26 PER TIMESTAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. A DRIVELINE COMMUNICATION FAULT ALARM WAS OBSERVED THROUGHOUT THE DATA. INTERMITTENT FAULTS FLAGS INDICATING THAT THE CONTROLLER WAS INTERMITTENTLY LOSING ITS SIGNAL WITH THE COMM-A LINE IN THE DRIVELINE WERE OBSERVED THROUGHOUT THE ALARM¿S DURATION. THE DRIVELINE COMMUNICATION FAULT ALARM REMAINED ACTIVE, AS THE ALARM LATCHES PER DESIGN, UNTIL THE DRIVELINE WAS DISCONNECTED ON 24APR2023 AT 11:26 TO CONDUCT THE REPORTED MODULAR CABLE AND SYSTEM CONTROLLER EXCHANGE. NO OTHER NOTABLE EVENTS WERE OBSERVED. THE RETURNED MODULAR CABLE (LOT NUMBER 7031760) WAS FUNCTIONALLY TESTED ALONGSIDE THE RETURNED SYSTEM CONTROLLER AND ALONGSIDE KNOWN WORKING TEST EQUIPMENT. WHILE THE CABLE WAS IN USE WITH A TEST SYSTEM CONTROLLER, A DRIVELINE COMMUNICATION FAULT ALARM BECAME ACTIVE, AND AN OPEN LINE WAS MEASURED IN THE CABLE, NARROWING THE CAUSE OF THE ISSUE TO THE MODULAR CABLE. THE CABLE WAS STRIPPED AND ITS CONDUCTORS WERE OBSERVED. THE CABLE¿S GREEN CONDUCTOR, WHICH IS RESPONSIBLE FOR THE CABLE¿S COMM-A LINE, BECAME FRACTURED UNDERNEATH THE END OF THE CONTROLLER-SIDE BEND RELIEF UPON LIGHT MANIPULATION. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE DAMAGE TO THE MODULAR CABLE¿S COMM-A CONDUCTOR AT THE END OF THE CONTROLLER-SIDE BEND RELIEF, CONSISTENT WITH THE REPETITIVE FLEXING OF THE CABLE OVER TIME. REVIEW OF THE DEVICE HISTORY RECORD FOR THE MODULAR CABLE, LOT NUMBER 7031760, SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE (QA) SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D, SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) INSTRUCTS USERS ON HOW TO RESOLVE ALARMS THAT SOUND FROM THEIR SYSTEM CONTROLLER, INCLUDING DRIVELINE COMMUNICATION FAULT ALARMS. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D, 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 ALSO 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 (SECTION TITLED ¿EMERGENCY CONTACT LIST¿). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DRIVELINE COMMUNICATION FAULT ADVISORY ALARM. THE PATIENT WAS ASYMPTOMATIC AND DID NOT REPORT ANY ACTIVE LOW FLOW OR HAZARD ALARMS, AND THE PUMP WAS CONFIRMED TO BE ON AND RUNNING WITH A GREEN PUMP RUNNING SYMBOL. THE PATIENT SILENCED THE ALARM AND VISITED THEIR CLINIC FOR EVALUATION. LOG FILE ANALYSIS CONFIRMED DRIVELINE COMMUNICATION A FAULTS ON (B)(6) 2023. THE MODULAR CABLE AND CONTROLLER WERE EXCHANGED WHICH RESOLVED THE ISSUE. RELATED CONTROLLER MFR #: 2916596-2023-02846.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160074 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7031760 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 Female