BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 19767651 · Received July 17, 2024

    Report

    Report Number
    2916596-2024-04379
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 30, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4: PATIENT WEIGHT NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    B5 : NARRATIVE INFORMATION NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER NOT COMMUNICATING WITH THE HEARTMATE TOUCH / SYSTEM MONITOR WAS CONFIRMED VIA THE CONTROLLER¿S TESTING. THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(6)) WAS OBSERVED TO HAVE DAMAGED WHITE CONNECTOR-SIDE STRAIN RELIEF UPON ARRIVAL AND WAS UNABLE TO COMMUNICATE TO A KNOWN WORKING TEST SYSTEM MONITOR. THE CONTROLLER WAS ABLE TO OPERATE A MOCK LOOP AS INTENDED DESPITE THE COMMUNICATION ISSUE. THE CONTROLLER WAS OPENED, AND ITS POWER CABLES WERE REPLACED WITH TEST POWER CABLES. AFTER THIS REPLACEMENT, COMMUNICATION WITH THE MONITOR WAS RESTORED. THE CONTROLLER¿S ORIGINAL POWER CABLES WERE OPENED, AND THE ORANGE WIRE WITHIN THE WHITE POWER CABLE WAS OBSERVED TO BE FRACTURED UNDERNEATH THE DAMAGED CONNECTOR-SIDE BEND RELIEF. THIS WIRE IS RESPONSIBLE FOR COMMUNICATING INFORMATION TO THE SYSTEM MONITOR FROM THE SYSTEM CONTROLLER, AND DAMAGE TO THIS WIRE WOULD PREVENT THE CONTROLLER FROM COMMUNICATING WITH THE MONITOR / HEARTMATE TOUCH. A LOG FILE WAS EXTRACTED FROM THE CONTROLLER DURING TESTING; HOWEVER, NO ATYPICAL EVENTS WERE OBSERVED, AND THE PUMP OPERATED AS INTENDED THROUGHOUT THE DATA. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO HAVE BEEN DAMAGE TO THE ORANGE WIRE WITHIN THE CONTROLLER¿S WHITE POWER CABLE WHICH MAY HAVE OCCURRED DUE TO THE OBSERVED POWER CABLE DAMAGE; HOWEVER, THE ROOT CAUSE OF THE POWER CABLE¿S DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED. INCIDENTAL FINDINGS: DAMAGED BLACK BEND RELIEF. FLUID INGRESS WITHIN BOTH CABLE JACKETS. FRACTURED WIRES UNDERNEATH THE DAMAGED WHITE STRAIN RELIEF THAT WERE UNRELATED TO THE CAUSE OF THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORD FOR THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK INSTRUCTS USERS TO NEVER SUBMERGE THEIR EQUIPMENT, INCLUDING THEIR SYSTEM CONTROLLER, UNDERWATER. THE PATIENT HANDBOOK ALSO INSTRUCTS USERS TO NEVER EXPOSE THEIR EQUIPMENT TO LIQUIDS OR FLUIDS OF ANY KIND. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 10 ¿SAFETY CHECKLISTS¿) INSTRUCTS USERS TO REGULARLY INSPECT THEIR EQUIPMENT, INCLUDING THEIR SYSTEM CONTROLLERS, AND TO AVOID USING EQUIPMENT THAT APPEARS DAMAGED. USERS ARE ENCOURAGED TO REPLACE ANY EQUIPMENT THAT APPEARS DAMAGED. 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

    IT WAS REPORTED THAT THE PATIENT WAS ATTEMPTED TO BE CONNECTED TO THE HM TOUCH MONITOR LOCATED IN WVU'S OUTPATIENT CLINIC. WHEN CONNECTING WHITE-TO-WHITE CABLES TO THIS PATIENT'S SYSTEM CONTROLLER, THE CONTROLLER CONNECTION SCREEN DID NOT APPEAR. THIS PATIENT CABLE HAD BEEN USED ON ANOTHER PATIENT PREVIOUSLY AND WAS NOT DEEMED TO BE THE ISSUE. THE HEARTMATE TOUCH APP AND THE HEARTMATE TOUCH (HMT) WERE BOTH HARD RESTARTED. THE SYSTEM CONTROLLER WAS STILL DRAWING POWER THROUGH THIS CONNECTION, NOT LEADING TO A POWER CABLE DISCONNECT WHILE ATTACHED. ONCE TROUBLESHOOTING WAS COMPLETE, THE CENTER OPTED TO EXCHANGE THE SYSTEM CONTROLLER WITH A NEW PRIMARY SYSTEM CONTROLLER. ON THIS NEW SYSTEM CONTROLLER, THE CONNECTION STARTED UP IMMEDIATELY. THE SYSTEM CONTROLLER WOULD BE RETURNED FOR ANALYSIS. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-04380 (HEARTMATE TOUCH).

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT RESTARTING THE HMT AND APP DID NOT RESOLVE THE ISSUE WHICH PROMPTED THE SYSTEM CONTROLLER EXCHANGE, AND IT APPEARED THAT THE SYSTEM CONTROLLER EXCHANGE RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150474 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8380039 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown