BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT

    MDR report key: 18722039 · Received February 16, 2024

    Report

    Report Number
    2916596-2024-00813
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 29, 2024
    Report Date
    May 22, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010784
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM WAS CONFIRMED VIA THE PROVIDED LOG FILE. THE LOG FILE CONTAINED DATA SPANNING APPROXIMATELY 4 DAYS ((B)(6) 2024 PER TIMESTAMP), AND THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. A NO EXTERNAL POWER ALARM WAS OBSERVED ON (B)(6) 2024 WHILE THE POWER MODULE PATIENT CABLE WAS IN USE. THE ALARM APPEARED TO HAVE BEEN CAUSED BY THE VOLTAGE WITHIN BOTH POWER CABLES DROPPING BELOW THE ALARM THRESHOLD. THE ALARM RESOLVED WITHIN APPROXIMATELY 1 MINUTE WHEN POWER WAS RESTORED TO THE SYSTEM. ALTHOUGH THE CAUSE OF THE ALARM WAS UNABLE TO BE DETERMINED FROM THE LOG FILE ALONE, THE PATIENT¿S VOLTAGE VALUES WERE ALSO OBSERVED TO BE BELOW-AVERAGE WHILE THE PATIENT CABLE WAS IN USE, WHICH MAY HAVE CONTRIBUTED TO THE CAUSE OF THE ALARM. THE 14-VOLT PATIENT CABLE (SERIAL/LOT NUMBER UNKNOWN) WAS NOT RETURNED FOR ANALYSIS. QUESTIONS REGARDING THE EVENT WERE ASKED MULTIPLE TIMES AND NO RESPONSES WERE RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE SERIAL/LOT NUMBER OF THE 14-VOLT PATIENT CABLE WAS NOT PROVIDED. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D, SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR, INCLUDING ALARMS ASSOCIATED WITH NO EXTERNAL POWER CONDITIONS. TO RESOLVE THE NO EXTERNAL POWER ALARM: 1. IMMEDIATELY CONNECT THE SYSTEM CONTROLLER POWER CABLES TO A WORKING POWER SOURCE (FUNCTIONING MOBILE POWER UNIT OR TWO FULLY-CHARGED HEARTMATE 14 VOLT LITHIUM-ION BATTERIES). 2. CALL YOUR HOSPITAL CONTACT IMMEDIATELY IF CONNECTING TO POWER DOES NOT RESOLVE THE ALARM. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D, SECTION TITLED "EMERGENCY CONTACT LIST") CAUTIONS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOG FILE REVIEW WAS REQUESTED FOR A PATIENT WHO WAS NOTED TO HAVE A NO EXTERNAL POWER (NEP) ALARM. THE EVENT LOG FILE CAPTURED NEP EVENTS 26JAN2024 AT 1849-1850 WHILE USING WALL POWER. IT APPEARED THAT BOTH POWER CABLE LEADS WERE DISCONNECTED AT THE SAME TIME ENABLING THE BACKUP BATTERY IN THE SYSTEM CONTROLLER UNTIL POWER WAS RESTORED TO THE MOBILE POWER UNIT / POWER MODULE. THE EVENT LASTED ABOUT 1 MINUTE WITH NO INTERRUPTION IN PUMP SUPPORT. TECHNICAL SERVICES NOTED THAT IF THE PATIENT WAS USING A POWER MODULE AT HOME, THE PATIENT CABLE NEEDED TO BE REPLACED AS IT WAS SHOWING BELOW THE 14V SPECIFICATIONS ON OCCASION. NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG FILE. IT WAS ADDITIONALLY COMMUNICATED THAT THE PATIENT WAS IN THE EMERGENCY ROOM AT THE TIME OF THE EVENT. THE SITE NOTED THAT IF THE PATIENT WAS HOOKED UP TO THE MPU, IT WAS LIKELY THE PATIENT'S HOME MPU AND IF THEY WERE ON THE POWER MODULE, IT WAS ONE FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450760 HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 103426 00813024010784

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male