BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 15799043 · Received November 15, 2022

    Report

    Report Number
    2916596-2022-14901
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 25, 2022
    Report Date
    July 18, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED DRIVELINE COMMUNICATION FAULT ALARMS WERE CONFIRMED VIA LOG FILE ANALYSIS. THE HEARTMATE III MODULAR CABLE (LOT #: 8103515) WAS RETURNED FOR ANALYSIS AND LOG FILES WERE SUBMITTED FOR REVIEW SPANNING APPROXIMATELY 6 DAYS (31MAY2002, 13SEPT2022 -14SEPT2022, 22OCT2022 -25OCT2022 PER TIMESTAMP) AND APPROXIMATELY 8 DAYS (25OCT2022 ¿ 02NOV2022 PER TIMESTAMP). EVENTS OCCURRING ON 31MAY2002 ARE FROM WHEN THE SYSTEM CLOCK WAS NOT SET AND EVENTS PRIOR TO 22OCT2022 ARE NOT RELATED TO THE REPORTED EVENT. THERE WERE DRIVELINE COMMUNICATION FAULTS ON 25OCT2022 AT 17:47:11 UNTIL THE END OF THE FIRST LOG FILE. ON 25OCT2022 AT 20:29:13 - 21:14:05 THERE WERE COM_B_FAULTS. THESE LATTER EVENTS DID NOT TRIGGER ALARMS, AND THESE CLEARED ON THEIR OWN. THERE WERE NO OTHER NOTABLE EVENTS IN THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED. THE HEARTMATE III MODULAR CABLE WAS TESTED AND WAS ABLE TO PASS ALL STAGES OF TESTING. THE CABLE WAS ABLE TO OPERATE ON A MOCK LOOP AND THE INTERNAL WIRES WERE ABLE TO PASS FUNCTIONAL TESTING. THE REPORTED ALARMS WERE NOT REPRODUCED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED IN THIS ANALYSIS. HEARTMATE III INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ EXPLAINS HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL ALARMS, INCLUDING DRIVELINE COMMUNICATION FAULTS ALARMS. HEARTMATE III INSTRUCTIONS FOR USE SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 ¿ ¿CARING FOR EQUIPMENT¿ EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT. 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 AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE (LOT #: 8103515) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION G1: CORRECTION.

    Description of Event or Problem · 0

    RELATED MFR # 2916596-2022-14898.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MULTIPLE COMMUNICATION FAULT ALARMS. THE CONTROLLER WAS SWAPPED BY THE PATIENT BUT IT DID NOT RESOLVE THE ALARMS. THE PATIENT WENT TO A CLINIC FOR ADDITIONAL TROUBLESHOOTING. LOG FILE CONFIRMED THE REPORTED DRIVELINE COMMUNICATION (B) FAULTS. ORIGINAL CONTROLLER WAS SWAPPED BACK WITH A NEW MODULAR CABLE ON (B)(6) 2022 WHICH APPEARED TO RESOLVE THE ALARMS. ADDITIONAL INFORMATION STATED THAT THE EVENT LOGS CONTAINED THE TAIL OF THE ORIGINAL EVENT SHUT DOWN SEQUENCE WITH ADDITIONAL DATA FOLLOWING YOUR MODULAR CABLE AND CONTROLLER SWAP. THESE LOGS APPEARED TO INDICATE THE COMMUNICATION B FAULTS RETURNED BETWEEN THE DATE STAMP OF (B)(6) 2022 AT 8:16PM AND 9:14PM. FOLLOWING THIS TIME FRAME, THE COMMUNICATION FAULT APPEARS TO RESOLVE AND DID NOT RETURN. THE PUMP WAS OPERATING NORMALLY. ANOTHER ADDITIONAL LOG REVIEW STATED THERE WERE NO COMM FAULT ALARMS SINCE (B)(6) 2022, 21:31. THE LOG CAPTURED LOW POWER ADVISORIES DUE TO NORMAL BATTERY DEPLETION ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207957 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8103515 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male