BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 16353975 · Received February 10, 2023

    Report

    Report Number
    2916596-2023-00825
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 27, 2023
    Report Date
    March 13, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENTS OF A DRIVELINE COMMUNICATION FAULT ALARM, AND THE MODULAR CABLE BEING DIFFICULT TO DISCONNECT, WERE BOTH CONFIRMED. THE PROVIDED AND EXTRACTED EVENT LOG FILES WERE REVIEWED, COLLECTIVELY CONTAINING DATA SPANNING APPROXIMATELY 7 DAYS (21JAN2023 ¿ 27JAN2023 PER TIMESTAMP AND 31JAN2023 ¿ 01FEB2023 PER TIMESTAMP). A FEW DRIVELINE COMMUNICATION FAULT ALARMS WERE OBSERVED, BEGINNING ON 27JAN2023, CORRELATING TO FAULT FLAGS THAT INDICATED THE CONTROLLER WAS UNABLE TO PROPERLY COMMUNICATE WITH THE PUMP¿S COMM A LINE. THE PATIENT¿S DRIVELINE WAS DISCONNECTED ON 01FEB2023 AT 12:48 TO CONDUCT THE REPORTED CONTROLLER EXCHANGE. THE RETURNED MODULAR CABLE (LOT NUMBER 7171212) WAS OBSERVED TO BE STUCK WITHIN THE RETURNED SYSTEM CONTROLLER UPON ARRIVAL (SERIAL NUMBER (B)(6), EVALUATED UNDER MFR #2916596-2023-00826), AS THE CONTROLLER¿S RELEASE BUTTON WOULD NOT DEPRESS. UPON REMOVING THE MOD CABLE THROUGH DISMANTLING THE CONTROLLER, FLUID INGRESS WAS OBSERVED WITHIN THE BULKHEAD CONNECTOR, AND HARDENED FLUID/RUST WAS OBSERVED ON THE BULKHEAD CONNECTOR. THE MOD CABLE WAS CONNECTED TO A MOCK LOOP AND WAS TESTED ALONGSIDE THE RETURNED SYSTEM CONTROLLER. A DRIVELINE COMMUNICATION FAULT WAS ACTIVE; HOWEVER, THE MOCK LOOP OPERATED AS INTENDED WHILE THE MOD CABLE WAS IN USE, EVEN WHEN THE CABLE WAS MANIPULATED BY HAND. THE MOD CABLE¿S INNER WIRES WERE MEASURED POINT-TO-POINT, AND ATYPICAL MEASUREMENTS WERE NOT OBSERVED. THE ROOT CAUSE OF THE REPORTED EVENTS WAS DETERMINED TO BE FLUID INGRESS WITHIN THE MOD CABLE AND THE CONTROLLER¿S BULKHEAD ASSEMBLY; HOWEVER, THE ROOT CAUSE OF THE FLUID INGRESS WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE MODULAR CABLE, LOT NUMBER 7171212, SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (REV. G) INSTRUCTS USERS TO NEVER SUBMERGE THEIR EQUIPMENT, INCLUDING THEIR SYSTEM CONTROLLER AND MODULAR CABLE, UNDERWATER. THE PATIENT HANDBOOK ALSO INSTRUCTS USERS TO NEVER EXPOSE THEIR EQUIPMENT TO LIQUIDS OR FLUIDS OF ANY KIND. THE HEARTMATE 3 PATIENT HANDBOOK (REV. G, 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 (REV. G, 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.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. INITIAL REPORTER PHONE NUMBER: (B)(6). INITIAL REPORTER EMAIL: (B)(6).

    Description of Event or Problem · 0

    THE DRIVELINE COMMUNICATION FAULT RESOLVED AFTER EXCHANGE OF THE CONTROLLER AND MODULAR CABLE. NO DRIVELINE POWER FAULTS WERE RECORDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN LOG FILES WERE DOWNLOADED FOR EVALUATION, A DRIVELINE COMMUNICATIONS FAULT APPEARED. THE DRIVELINE ALARM WAS CLEARED VIA THE SYSTEM MONITOR, HOWEVER IT REAPPEARED IMMEDIATELY. THE CONTROLLER AND MODULAR CABLE WERE EXCHANGED. AFTER THE EXCHANGE THE DRIVELINE POWER FAULT RESOLVED. THE MODULAR CABLE WAS UNABLE TO BE REMOVED FROM THE CONTROLLER. THE PATIENT WAS STABLE. CONTROLLER MFR # 2916596-2023-00826.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079774 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 7171212 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown