BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 14241129 · Received April 28, 2022

    Report

    Report Number
    2916596-2022-10688
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    January 16, 2022
    Report Date
    April 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q419-MCS-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT DEATH IS REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2022-00560. MANUFACTURER'S INVESTIGATION CONCLUSION: EVIDENCE OF AN IMPROPER CONNECTION BETWEEN THE MODULAR CABLE AND THE SYSTEM CONTROLLER BY 180 DEGREES WAS CONFIRMED THROUGH THE EVALUATION OF THE RETURNED MODULAR CABLE. THE ACCOUNT REPORTED THAT THE PATIENT WAS FOUND DECEASED AT HOME ON (B)(6) 2022. AN EVENT LOG FILE WAS DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(4)), WHICH IS INVESTIGATED UNDER (B)(4). THE LOG FILE CONTAINED RELEVANT DATA FROM 17:25:21 ON (B)(6) 2022 THROUGH 02:09:59 ON (B)(6) 2022, PER THE TIMESTAMPS. AT 23:15:14 ON (B)(6) 2022, THE DRIVELINE APPEARED TO BE DISCONNECTED, CAUSING THE PUMP TO STOP. AT 23:47:24 ON 16JAN2022, A CONTROLLER INTERNAL FAULT ALARM WAS CAPTURED, ASSOCIATED WITH FUSE B BEING OPEN. THE DRIVELINE REMAINED DISCONNECTED FOR THE REMAINDER OF THE DATA, AND THE CONTROLLER FAULT ALARM DUE TO FUSE B BEING OPEN REMAINED ACTIVE UNTIL A SHUTDOWN SEQUENCE WAS STARTED AND THE CONTROLLER WAS PUT INTO SLEEP MODE AT 02:09:59 ON (B)(6) 2022. NO OTHER NOTABLE EVENTS OR ALARMS WERE OBSERVED IN THE LOG FILE. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED WITHOUT ISSUE WHILE THE DRIVELINE WAS CONNECTED. THE HEARTMATE 3 MODULAR CABLE, LOT NUMBER 190294, WAS RETURNED IN USED CONDITION WITH (B)(4), PROPERLY ATTACHED TO THE PUMP CABLE INLINE CONNECTOR. UPON EXAMINATION OF THE RETURNED MODULAR CABLE, INSPECTION OF THE CONTROLLER CONNECTOR REVEALED A BURN MARK ON ONE OF THE PINS. THE INTEGRITY OF THE INTERNAL WIRES OF THE MODULAR CABLE WAS TESTED, AND THE MODULAR CABLE PASSED MANUFACTURING TEST PROCEDURE AND WAS DETERMINED TO FUNCTION AS INTENDED. THE MODULAR CABLE WAS THEN CONNECTED TO A TEST PUMP AND SYSTEM CONTROLLER WITHOUT ISSUE. THE MODULAR CABLE OPERATED IN A MOCK CIRCULATORY LOOP WITHOUT ANY ISSUES OR ATYPICAL ALARMS ACTIVATED. THE DATA IN THE RETRIEVED CONTROLLER LOG FILE, FUNCTIONAL TESTING, AND BURNT PIN IN THE CONTROLLER CONNECTOR OF THE RETURNED MODULAR CABLE ARE CONSISTENT WITH THE DRIVELINE BEING INSERTED INTO THE CONTROLLER INCORRECTLY BY 180 DEGREES. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO ADDRESS THE ISSUE OF 180-DEGREE CONNECTION OF THE MODULAR CABLE TO THE HM3 SYSTEM CONTROLLER AND AS A RESULT, THE DRIVELINE CONNECTOR WAS REDESIGNED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MODULAR CABLE WAS SHIPPED IN THE IMPLANT KIT FOR (B)(4) ON 07JUN2017. THE HEARTMATE 3 LEFT VENTRICULAR ASIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. C ARE CURRENTLY AVAILABLE. SECTION 2 OF THE IFU, "SYSTEM OPERATIONS" (UNDER "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER"), PROVIDES INSTRUCTIONS ON CONNECTING/DISCONNECTING THE DRIVELINE TO/FROM THE SYSTEM CONTROLLER AND MAKING SURE THAT IT IS FULLY AND PROPERLY INSERTED INTO THE SYSTEM CONTROLLER SOCKET. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER "CARING FOR THE DRIVELINE"), INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 8 OF THE IFU, "EQUIPMENT STORAGE AND CARE" (UNDER "CLEANING THE DRIVELINE"), STATES, "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." SECTION 4 OF THE PATIENT HANDBOOK, "LIVING WITH THE HEARTMATE III" (UNDER "CARING FOR THE DRIVELINE"), CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER: "CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)" AND "KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID." SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. ADDITIONALLY, SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. FURTHERMORE, THE 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBERS: 2916596-2022-00560 AND 2916596-2022-01881. IT WAS REPORTED THAT THE PATIENT WAS FOUND DECEASED AT HOME (B)(6) 2022. THE CAUSE OF DEATH WAS UNKNOWN. EVALUATION OF THE RETURNED MODULAR CABLE REVEALED AN IMPROPER CONNECTION BETWEEN THE MODULAR CABLE AND THE SYSTEM CONTROLLER BY 180 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119443 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 190294 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male