BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 18643015 · Received February 5, 2024

    Report

    Report Number
    2916596-2024-00784
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 28, 2024
    Report Date
    June 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1: CORRECTED SECTION D4: CORRECTED MODEL, CATALOG NUMBER AND UDI MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE POWER FAULT ALARM WAS CONFIRMED VIA THE SUBMITTED LOG FILE; HOWEVER, THE ALARM WAS NOT REPRODUCED DURING TESTING OF THE RETURNED MODULAR CABLE (LOT NUMBER: 7190963). THE REPORTED EVENT OF DISCOLORATION OF THE MODULAR CABLE WAS CONFIRMED. THE CONTROLLER EVENT LOG FILE CONTAINED DATA SPANNING 24 DAYS ((B)(6) 2024 PER THE TIMESTAMP). A DRIVELINE POWER FAULT ALARM ACTIVATED AT 6:24:07 ON (B)(6) 2024 DUE TO THE CURRENT ON LINE B DROPPING BELOW THE THRESHOLD AMPERAGE. THE ALARM REMAINED ACTIVE FOR THE REMAINDER OF THE LOG FILE, WHICH ENDED AT 7:42:08 ON (B)(6) 2024. THE PUMP MAINTAINED A SPEED WITHIN THE EXPECTED RANGE WITHOUT ISSUE THROUGHOUT THE LOG FILE. VISUAL INSPECTION OF THE RETURNED MODULAR CABLE REVEALED A GREY/BROWN DISCOLORATION OF THE POLYURETHANE JACKET AND STRAIN RELIEFS. NO OTHER PHYSICAL ANOMALIES WERE OBSERVED. THE UNDERLYING WIRES WERE TESTED, AND NO ISSUES WERE OBSERVED. THE MODULAR CABLE WAS FUNCTIONALLY TESTED WITH A TEST SYSTEM CONTROLLER ON A MOCK CIRCULATORY LOOP AND WAS FOUND TO FUNCTION AS INTENDED WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. IT WAS REPORTED THAT THE EXCHANGED SYSTEM CONTROLLER WILL NOT BE RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK (REV. D), UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE DRIVELINE POWER FAULT, POWER CABLE DISCONNECT, NO EXTERNAL POWER, AND LOW VOLTAGE HAZARD CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C), SECTION 2 "SYSTEM OPERATIONS" (UNDER "REPLACING THE MODULAR CABLE") PROVIDES INSTRUCTIONS ON HOW TO REPLACE THE MODULAR CABLE. SECTION 5 "SURGICAL PROCEDURES" CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 "PATIENT CARE AND MANAGEMENT" CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS SECTION FURTHER CAUTIONS: "DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, THE POWER MODULE PATIENT CABLE, OR THE MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN." SECTION 6 (UNDER "CARING FOR THE DRIVELINE") INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 7 "ALARMS AND TROUBLESHOOTING" PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". SECTION 8 "EQUIPMENT STORAGE AND CARE" (UNDER "CLEANING THE DRIVELINE") STATES, "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 4 "LIVING WITH THE HEARTMATE III" (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER: "CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." AND "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." IN ADDITION, SECTION 5 "ALARMS AND TROUBLESHOOTING" CONTAINS A SUB-SECTION 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 (REV. D) 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT ALL ALARMS WERE RESOLVED AFTER SYSTEM CONTROLLER AND MODULAR CABLE REPLACEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH VENTRICULAR ASSIST DEVICE (VAD) ALARMS. THE PATIENT STATED THEY HAD JUST ARRIVED AT THEIR DIALYSIS CLINIC WHEN THE VAD BEGAN ALARMING DRIVELINE POWER FAULT ALARMS. THE CAREGIVER BROUGHT THE PATIENT TO THE ED IMMEDIATELY. UPON REVIEWING THE SYSTEM CONTROLLER PARAMETERS, ALL APPEARED NORMAL WITH THE EXCEPTION OF THE DRIVELINE POWER FAULT ALARM. FILES WERE DOWNLOADED AND PREPARATION WAS MADE TO REPLACE THE MODULAR CABLE. THE PATIENT TOLERATED THE REPLACEMENT WELL AND THE SYSTEM PERFORMED AS INTENDED WITHOUT ANY ALARMS ONCE THE NEW MODULAR CABLE WAS PUT INTO OPERATION. LOG FILES WERE SUBMITTED FOR REVIEW AND CONFIRMED THE REPORTED DRIVELINE POWER FAULT. THE FAULT APPEARED TO BE ASSOCIATED WITH ABNORMAL MONITORED VALUES FROM POWER LINE B. THE PUMP ITSELF APPEARED TO BE OPERATING WITHIN NORMAL PARAMETERS. THE PATIENT DID NOT REPORT ANY WATER INGRESS AND THERE WERE NO REAL OVERT SIGNS OF TRAUMA NOR DAMAGE TO THE MODULAR CABLE. IT WAS UNIFORMLY DISCOLORED A GRAY COLOR FROM AGE BUT DISPLAYED NO EVIDENCE OF SHEATH TEARS NOR ACUTE ANGLE BENDS WHICH WOULD BE SUSPICIOUS. THE MODULAR CABLE WOULD BE RETURNED FOR EVALUATION. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-00785.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874777 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7190963 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female