BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 14622170 · Received June 7, 2022

    Report

    Report Number
    2916596-2022-11529
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 26, 2022
    Report Date
    June 28, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE FAULT ALARM WAS UNABLE TO BE CONFIRMED. THE MODULAR CABLE (LOT NUMBER: 181912) WAS RETURNED FOR ANALYSIS AND A LOG FILE WAS DOWNLOADED, FROM THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) ), FOR REVIEW; HOWEVER, THE LOG FILE DID NOT CONTAIN ANY EVENTS THAT PERTAINED TO THE REPORTED EVENT FOR THE MODULAR CABLE. THE RETURNED MODULAR CABLE FUNCTIONED AS INTENDED DURING ANALYSIS. THE MODULAR CABLE WAS CONNECTED TO THE RETURNED SYSTEM CONTROLLER AND A TEST PUMP AND SUCCESSFULLY OPERATED THE TEST PUMP WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED, INCLUDING WHEN THE MODULAR CABLE WAS MANIPULATED BY HAND. THE INTEGRITY OF THE WIRES IN THE RETURNED MODULAR CABLE WERE THEN TESTED AND THE CABLE PASSED TESTING WITHOUT ANY ISSUES. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE VAD MODULAR CABLE (LOT NUMBER: 181912) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. CUSTOMER ORDER WAS SHIPPED ON 26OCT2016. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (AUDITORY AND VISUAL), INCLUDING DRIVELINE POWER FAULT ALARMS AND THE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. THESE SECTIONS ALSO CONTAIN A SUBSECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES", WHICH EXPLICITLY CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. HEARTMATE 3 PATIENT HANDBOOK SECTION 4 ¿ ¿LIVING WITH THE HEARTMATE 3¿ EXPLAINS HOW TO PROPERLY CARE FOR THE DRIVELINE AND STATES, ¿KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID¿. HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ¿ ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION THE USER 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 THE PATIENT HAD DRIVELINE FAULT ALARMS ON THEIR CONTROLLER. THE MODULAR CABLE WAS EXCHANGED WHICH RESULTED IN THE PATIENT TRANSITIONING TO HIS BACKUP CONTROLLER. THE DRIVELINE FAULT ALARM IMMEDIATELY STOPPED AFTER THE EXCHANGE. SHORTLY AFTER, THE CONTROLLER (WAS THE BACKUP CONTROLLER) DEVELOPED A CONTROLLER FAULT ALARM AND YELLOW WRENCH ALARM. THE CONTROLLER WAS THEN CHANGED BACK TO HIS PRIMARY CONTROLLER. THE PATIENT TOLERATED THIS WELL AND THE CONTROLLER FAULT ALARM RESOLVED. THE PATIENT WAS KEPT IN THE CLINIC FOR SEVERAL MINUTES IN AN ATTEMPT TO REPLICATE THE ALARM AND WAS ABLE TO REMAIN WITHOUT NEW ALARMS. RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-11528.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578975 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 181912 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male