BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 14957847 · Received July 8, 2022

    Report

    Report Number
    2916596-2022-11893
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 8, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION THE REPORTED EVENT OF A DRIVELINE COMMUNICATION FAULT WAS CONFIRMED VIA THE SUBMITTED LOG FILES. A REVIEW OF THE SUBMITTED LOG FILES CONTAINED DATA SPANNING APPROXIMATELY 12 DAYS (10JUN22 ¿ 21JUN22 PER TIMESTAMP). ON 17JUN22 FROM 18:00:43 ¿ 18:49:21 AND 20:36:22 ¿ 20:45:47, DRIVELINE COMMUNICATION FAULT ALARMS ACTIVATED DUE TO COM_B_FAULTS AND COM_A_FAULTS INTERMITTENTLY ACTIVATING FROM 17:59:31 ¿ 18:0057 AND 20:36:12 ¿ 20:44:12. ON 17JUN22 AT 21:11:42 A DRIVELINE COMMUNICATION FAULT ALARM WAS ACTIVE. THE PERIODIC LOG FILE CAPTURES EVENTS AT DESIGNATED INTERVALS AND SO THE ONSET OF THE DRIVELINE COMMUNICATION FAULT ALARM WAS NOT RECORDED. THE ALARMS DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE HEARTMATE 3 SYSTEM CONTROLLER (S/N: HSC-112249) WAS RETURNED FOR ANALYSIS IN UNREMARKABLE CONDITION. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND WAS FOUND TO OPERATE AS INTENDED DURING ANALYSIS. ADDITIONAL TESTING WAS PERFORMED WITH THE RETURNED MODULAR CABLE. THE CONTROLLER WAS CONNECTED TO THE RETURNED MOD CABLE, A MOCK LOOP AND SYSTEM MONITOR AND ALLOWED TO RUN FOR AN EXTENDED PERIOD OF TIME. THE POWER CABLES AND MOD CABLE WERE FLEXED TO NO AFFECT. THE SYSTEM OPERATED AS INTENDED AND NO ALARMS WERE REPRODUCED. THE BULKHEAD CONNECTOR WIRE RESISTANCES WERE TESTED AND FOUND TO BE WITHIN THE ACCEPTED RESISTANCE THRESHOLD OF 0.5 OHMS. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. C, SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK, REV. D, SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING DRIVELINE COMMUNICATION FAULT ALARMS. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. C, SECTION 8 - ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK, REV. D, SECTION 6 - ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE. 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. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-11892. IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE COMMUNICATE FAULT ALARM WITH A YELLOW WRENCH ON THE SCREEN OF THEIR CONTROLLER. THE PATIENT WAS IN THE EMERGENCY ROOM (ER) FOR LOW INTERNATIONAL NORMALIZED RATIO (INR) OF 1.3 DUE TO EATING A LARGE AMOUNT OF SPINACH AND HAVING A NOSE BLEED. THE PATIENT WAS STABLE AND WAS PLACED ON A HEPARIN (PORCINE) DRIP. THE LOG FILE CONFIRMED THE DRIVELINE COMMUNICATE FAULT ALARM WAS A COMM B FAULT STARTING AT 1759 ON (B)(6) 2022. AN X-RAY WAS SUBMITTED FOR REVIEW AND NO OBVIOUS AREAS OF CONCERN WERE FOUND. THE VENTRICULAR ASSIST DEVICE COORDINATOR TIGHTENED THE LOCK ON THE MODULAR DRIVELINE WHICH SET OFF ANOTHER ALARM AND WAS CLEARED. THE ALARMS APPEARED TO HAVE RESOLVED FOLLOWING THE MODULAR CABLE TIGHTENING. AN UNUSUALLY LOW POWER READING ON (B)(6) 2022 MAY ALSO HAVE BEEN A RESULT OF THE POOR MODULAR CABLE CONNECTION. THE MODULAR CABLE AND THE CONTROLLER WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2850094 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8388080 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male