BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17031537 · Received May 31, 2023

    Report

    Report Number
    2916596-2023-02804
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 7, 2023
    Report Date
    September 5, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER AND COMMUNICATION FAULT ALARMS WAS ABLE TO BE CONFIRMED VIA REVIEW OF THE LOG FILES; HOWEVER, WAS UNABLE TO BE REPRODUCED DURING TESTING. THE MODULAR CABLE (LOT NUMBER: 7902429) WAS RETURNED FOR ANALYSIS, AND A LOG FILE WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILES SHOWED EVENTS SPANNING APPROXIMATELY 7 DAYS ((B)(6) 2023 PER TIMESTAMP). DRIVELINE COMMUNICATION FAULT ALARMS CONSISTENT WITH COM B FAULTS WERE ACTIVE ON (B)(6) 2023 FROM 05:57:18 ¿ 09:50:24. THE ALARMS ESCALATED TO COMM A AND COMM B FAULTS ON (B)(6) 2023 AT 09:48:22. THE PUMP WAS STILL IN OPERATION; HOWEVER, THE CONTROLLER WAS UNABLE TO MONITOR THE ESTIMATED FLOW AND AVERAGE PI. DRIVELINE POWER FAULT ALARMS WERE ACTIVE ON (B)(6) 2023 AT 09:48:26 CAUSING THE PUMP TO BRIEFLY STOP. THE ALARMS CONTINUED THROUGH THE END OF THE LOG FILE WHEN THE DRIVELINE WAS DISCONNECTED. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2023 AT 09:48:31 AND THE CONTROLLER WAS SHUT DOWN AT 09:50:24. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOGFILE. THE DEVICE APPEARED TO FUNCTION AS INTENDED. ADDITIONAL LOG FILES WERE SUBMITTED FROM THE BACKUP CONTROLLER FOLLOWING THE REPORTED CONTROLLER EXCHANGE AND THE ALARMS PERSISTED POST EXCHANGE. MODULAR CABLE WAS CONNECTED TO THE MODULAR TESTER AND DID NOT PASS DUE TO THE AMOUNT OF CORROSION IN THE INLINE CONNECTOR. THE CONNECTOR WAS ATTEMPTED TO BE CLEANED; HOWEVER, THE CORROSION WAS UNABLE TO BE REMOVED. THE INLINE CONNECTOR WAS OBSERVED UNDER A MICROSCOPE AND EXTENSIVE CORROSION AT THE BASE OF THE PINS WAS OBSERVED. THE MODULAR CABLE WAS ALSO CONNECTED AND FUNCTIONALLY TESTED WITH A TEST HEARTMATE 3 SYSTEM CONTROLLER IN THE LABS AT ABBOTT AND WAS FOUND TO OPERATE AS INTENDED. THE MODULAR CABLE WAS ABLE TO OPERATE A PUMP WITH NO ALARMS ACTIVE. THE MODULAR CABLE WAS INSERTED INTO THE MODULAR V4 TESTER FOLLOWING THE MOCK LOOP TESTING AND DID NOT PASS. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION; HOWEVER, THE EXTENSIVE CORROSION OF THE INLINE CONNECTOR MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MODULAR CABLE (LOT NUMBER: 7902429) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. HEARTMATE III INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING DRIVELINE FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE III INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE AND ADVISES THE PATIENT NOT TO GET THEIR EQUIPMENT WET. HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THE IFU AND PATIENT HANDBOOK CONTAINS INFORMATION ON CARING FOR THE DRIVELINE IN SECTION 4 ¿LIVING WITH THE HEARTMATE 3". IN SEVERAL SECTIONS, THIS DOCUMENT WARNS THE USER TO NEVER PUT THE DRIVELINE, SYSTEM CONTROLLER, OR ANY EXTERNAL EQUIPMENT INTO WATER OR LIQUID; IMMERSION IN WATER OR LIQUID MAY CAUSE THE PUMP TO STOP. SECTION 4 "LIVING WITH THE HEARTMATE 3" OF THE PATIENT HANDBOOK (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THE PATIENT HANDBOOK 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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE MODULAR CABLE WAS INSERTED INTO THE MODULAR V4 TESTER FOLLOWING THE MOCK LOOP TESTING AND DID NOT PASS. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION; HOWEVER, THE EXTENSIVE CORROSION OF THE INLINE CONNECTOR MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRIVELINE FAULT ALARM. THE CONTROLLER WAS EXCHANGED TO THE BACKUP CONTROLLER ALONG WITH THE MODULAR CABLE. THE POWER FAULT ALARMS CLEARED BUT THE COMMUNICATION FAULT WAS UNABLE TO BE CLEARED. THE LOG FILE CAPTURED DRIVELINE COMM FAULT ALARMS SINCE THE CONTROLLER WAS CONNECTED ON (B)(6) 2023 AT 0944. THERE WERE ALSO DRIVELINE POWER FAULT ALARMS BETWEEN 0944 AND 0948 THAT HAD CLEARED. GIVEN THE COMMUNICATION FAULT ALARM WAS ACTIVE FOLLOWING A CONTROLLER AND MODULAR CABLE EXCHANGE, THERE COULD BE A POSSIBLE DAMAGE TO ONE OF THE COMMUNICATION WIRES (B) WITHIN THE DRIVELINE. IT WAS RECOMMENDED TO GET X-RAY IMAGES OF THE DRIVELINE. THERE WAS NO NOTICEABLE AREA OF DAMAGE BETWEEN THE EXIT SITE AN THE MODULAR CONNECTOR AND X-RAYS WERE TO BE OBTAINED. NO FURTHER AUDIBLE ALARMS WERE NOTED. REPEAT LOG FILES FROM BOTH CONTROLLERS WERE SUBMITTED FOR ANALYSIS. THE LOG FILES FROM THEIR CURRENT CONTROLLER CAPTURED CONSTANT DRIVELINE COMMUNICATION FAULTS THROUGHOUT THE LOG SHOWING INTERMITTENT COMMUNICATION FAULTS ON LINE B. THE LOG FILES FROM THE EXCHANGED CONTROLLER SHOWED THAT THE COMMUNICATION FAULTS STATED ON (B)(6) 2023 AT 0557 AND CONTINUED TO THE REMAINDER OF THE LOG SHOWING COMM B FAULTS INTERMITTENTLY. THE PATIENT WAS SEEN ON (B)(6) 2022 AND THERE WERE NO VISIBLE DAMAGE, TRAUMA, DEBRIS, OR MOISTURE CONCERNS. X-RAYS WERE REVIEWED AND THE BEND IN THE DRIVELINE WAS SUSPECTED TO BE THE POTENTIAL CAUSE. AFTER DISCUSSION WITH THE TEAM, THERE WERE NO NEW COMM FAULT ALARMS ON THE CONTROLLER. THE ALARM WAS PERMANENTLY SILENCED AND WAS SHOWING UP ON THE SYSTEM MONITOR AS INTENDED. RELATED MFR # FOR THE PUMP: 2916596-2023-02800. RELATED MFR # FOR THE CONTROLLER: 2916596-2023-02801.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018245 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7902429 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male