BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 14568024 · Received June 1, 2022

    Report

    Report Number
    2916596-2022-11042
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 14, 2022
    Report Date
    August 30, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION THE REPORTED EVENT OF COMMUNICATION FAULTS WAS ABLE TO BE CONFIRMED VIA REVIEW OF THE LOG FILE; HOWEVER, WERE UNABLE TO BE CONFIRMED VIA PRODUCT TESTING. THE MODULAR CABLE (LOT NUMBER: 8240775) WAS RETURNED FOR ANALYSIS, AND A LOG FILE WAS SUBMITTED FOR REVIEW AND ANOTHER WAS DOWNLOADED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILES SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 5 DAYS (B)(6) 2000, (B)(6) 2022 ¿ (B)(6) 2022, (B)(6) 2022 PER TIMESTAMP). EVENTS CAPTURED ON (B)(6) 2022 TOOK PLACE IN THE TESTING LABS AT ABBOTT. EVENTS CAPTURED ON (B)(6) 2000 TOOK PLACE WHEN THE CLOCK WAS NOT SET; THEREFORE, THE EXACT DATES AND TIMES WERE UNABLE TO BE ACCURATELY RECORDED. THE CLOCK WAS SET TO (B)(6) 2022 AT 16:24:50. CONTROLLER INTERNAL FAULTS COINCIDENT WITH COMMUNICATION A AND B FAULTS AND TIMEBASE FAULTS WERE INTERMITTENTLY ACTIVE ON (B)(6) 2022 FROM 00:02:41 ¿ 00:02:45 AND CLEARED SHORTLY AFTER ACTIVATING. LOSS OF LVAD COMMUNICATION ALARMS WERE INTERMITTENTLY ACTIVE RESULTING IN A PUMP STOPS WHICH WERE INTERMITTENTLY ACTIVE ON (B)(6) 2022 FROM 00:02:59 ¿ 00:15:58. THE ALARMS CLEARED SHORTLY AFTER ACTIVATING. THE LOSS OF COMMUNICATION INDICATED THAT THERE WAS A PUMP STOP; HOWEVER, THE PUMP MAY STILL HAVE BEEN IN OPERATION. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2022 AT 04:10:52 AND THE CONTROLLER WAS SHUT OFF AT 04:20:34. THERE WERE NO OTHER NOBLE ALARMS ACTIVE IN THE LOG FILE. THE MODULAR CABLE UNDERWENT PRELIMINARY AND FUNCTIONAL TESTING AND PASSED. THE SYSTEM CONTROLLER WAS CONNECTED TO A MOCK LOOP WITH THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) AND WAS ABLE TO OPERATE AS INTENDED WITH NO ALARMS ACTIVE. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. HEARTMATE III INSTRUCTIONS FOR USE, REV. D, SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK, REV. D, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING CONTROLLER FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. 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. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MODULAR CABLE (LOT NUMBER: 8240775) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-11041. IT WAS REPORTED THAT THE PATIENT HAD A COMMUNICATION FAULT ON THEIR SYSTEM CONTROLLER. THE CUSTOMER CALLED THE MANUFACTURER FOR ASSISTANCE. PLANS WERE MADE TO INSPECT THE DRIVELINE, REPLACE THE MODULAR CABLE, USE THE BACKUP CONTROLLER FOR A REPLACEMENT TO SEE IF THE ALARM RESOLVED, AND SEND IN LOG FILE TO TECHNICAL SERVICES. THE PATIENT WAS STABLE AND PUMP FUNCTION WAS NOT IMPACTED. THE PATIENT WAS RECOVERING FROM AN INITIAL VENTRICULAR ASSIST DEVICE (VAD) IMPLANT IN THE CARDIAC INTENSIVE CARE UNIT (ICU). LOG FILES SHOWED A CONTROLLER INTERNAL FAULT ALARM WAS RECORDED ON (B)(6) 2022 AT 0241 CONTINUING INTERMITTENTLY THROUGH TO (B)(6) 2022 AT 1558. DURING THIS PERIOD, THERE WERE SEVERAL EVENTS RECORDED THAT INDICATE AN ACTUAL MOTOR SPEED OF 0 RPMS. THESE EVENTS DO NOT APPEAR TO BE ACTUAL MOTOR STOPPED EVENTS BUT MAY HAVE BEEN DUE TO A LOSS OF COMMUNICATION BETWEEN THE SYSTEM CONTROLLER AND THE (LEFT VENTRICULAR ASSIST DEVICE) LVAD PUMP. MANIPULATION OF THE DRIVELINE DID NOT REPLICATE THE ALARM. THE MODULAR CABLE AND CONTROLLER WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461137 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8240775 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male