BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 14656004 · Received June 10, 2022

    Report

    Report Number
    2916596-2022-11365
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 29, 2022
    Report Date
    June 30, 2022
    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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL 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 DRIVELINE POWER FAULT ALARM CONFIRMED VIA LOG FILE ANALYSIS. THE MODULAR CABLE (LOT NUMBER: 7232316) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG WAS SUBMITTED (B5291028) FOR REVIEW AND SHOWED EVENTS SPANNING APPROXIMATELY 12 DAYS (B)(2020, (B)(6) 2021, (B)(6) 2022 PER TIME STAMP). EVENTS OCCURRING PRIOR TO (B)(6) 2022 WERE RECORDED WHILE THE DRIVELINE WAS NOT CONNECTED TO THE SYSTEM CONTROLLER AND ARE CONSISTENT WITH BACKUP SYSTEM CONTROLLER DATA. THE DRIVELINE WAS CONNECTED TO THE SYSTEM CONTROLLER ON (B)(6) 2022 AT 10:18:03. SHORTLY AFTER, A DRIVELINE POWER FAULT ALARM BECAME INTERMITTENTLY ACTIVE ON (B)(6) 2022 FROM 10:18:04 ¿ 10:22:10 DUE TO A POWER A BROKEN FAULT. PUMP OPERATION WAS NOT AFFECTED BY THIS ALARM. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. MULTIPLE GOOD FAITH EFFORTS WERE SENT REGARDING CLARIFICATION FOR THE REASON THE PRODUCTS WERE EXCHANGED, RESOLUTION OF THE REPORTED EVENT, AND IF ANY PRODUCT WOULD BE RETURNED TO ABBOTT FOR EVALUATION. TO DATE, NO RESPONSE HAS BEEN RECEIVED. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE UNABLE TO BE REVIEWED FOR THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 7232316) DUE TO THE RECORDS BEING UNAVAILABLE. 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

    RELATED MFR#: 2916596-2022-11364. IT WAS REPORTED THAT THE PATIENT HAD DRIVELINE POWER FAULTS. THE MODULAR CABLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893061 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7232316 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male