BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17748991 · Received September 14, 2023

    Report

    Report Number
    2916596-2023-06654
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    July 26, 2023
    Report Date
    September 14, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS PREVIOUSLY REPORTED UNDER MFR #'S 2916596-2023-05829. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS WAS CONFIRMED VIA LOG FILE ANALYSIS. A REVIEW OF LOG FILES, EXTRACTED FROM HSC-082362, CONTAINED DATA SPANNING APPROXIMATELY 12 DAYS ((B)(6) 2019, (B)(6) 2020, (B)(6) 2021, (B)(6) 2021, (B)(6) 2022, (B)(6) 2022, (B)(6) 2023, (B)(6) 2023 PER TIMESTAMP). ON 26JUL2023 AT 11:14:35, A PWR B BROKEN FAULT FLAG ACTIVATED. AT 11:14:37, THE PWR B BROKEN FAULT FLAG TRIGGERED DRIVELINE POWER FAULT ALARMS TO ACTIVATE. THE ALARM RESOLVED ON ITS OWN AT 11:17:24. PUMP OPERATION WAS NOT AFFECTED. A REVIEW OF LOG FILES, EXTRACTED FROM HSC-082362, CONTAIN DATA SPANNING APPROXIMATELY 5 DAYS ((B)(6) 2023 ¿ (B)(6) 2023 PER TIMESTAMP). FROM THE BEGINNING OF THE LOG FILES, (B)(6) 2023 AT 21:42:28, DRIVELINE POWER FAULT ALARMS WERE ACTIVE. THE ONSET OF THE ALARMS WAS NOT RECORDED AS THE EVENTS WERE OVERWRITTEN. THE ALARMS RESOLVED ONCE THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2023 AT 10:56:03, CONSISTENT WITH THE REPORTED SUPERIOR MODULAR CABLE CONNECTOR CLEANING. THE DRIVELINE WAS RECONNECTED AT 10:58:15. NO DRIVELINE POWER FAULT ALARMS WERE OBSERVED AFTER THE CLEANING. THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 8854654) WAS NOT RETURNED FOR ANALYSIS AND REMAINS IN USE. NO PHOTOS OR ADDITIONAL DOCUMENTS WERE SUBMITTED FOR REVIEW. PER THE PROVIDED INFORMATION, THE MOD CABLE WAS PUT INTO USE ON (B)(6) 2023. THE SUPERIOR MODULAR CABLE CONNECTION WAS CLEANED OF FLUID INGRESS ON (B)(6) 2023. THE DRIVELINE POWER FAULT ALARMS RESOLVED FOLLOWING THE PROCEDURE. A ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE FLUID INGRESS IN THE SUPERIOR MODULAR CABLE CONNECTOR; HOWEVER, A ROOT CAUSE OF HOW THE FLUID INGRESS OCCURRED WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE III INSTRUCTIONS FOR USE (IFU) SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE AND ADVISES THE PATIENT NOT TO GET THEIR EQUIPMENT WET. HEARTMATE III INSTRUCTIONS FOR USE SECTION 2 - ¿SYSTEM OPERATIONS¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 2 - ¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. 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. 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 MODULAR CABLE WAS EXCHANGED DUE TO DAMAGE ON THE ENTIRETY OF THE CABLE, AND AT THE SAME TIME THE PATIENT'S SYSTEM CONTROLLER WAS EXCHANGED TO THEIR BACKUP CONTROLLER. IT WAS NOTED THAT THE ORIGINAL CONTROLLER WAS EXCHANGED DUE TO SIGNIFICANT DAMAGE TO THE BLACK POWER LEAD, AND THE BATTERY DRAINED FASTER WHEN ATTACHED TO THAT LEAD. LOG FILES FROM THE ORIGINAL CONTROLLER RECORDED A COUPLE OF BRIEF (F20) COM_B_FAULT FLAGS. THESE DID NOT PERSIST LONG ENOUGH TO GENERATE A DRIVELINE COMM FAULT. AFTER THE EXCHANGE A SELF-TEST WAS COMPLETED AND PASSED, BUT THEN ABOUT 5 MINUTES LATER THE PATIENT WAS GETTING A DRIVELINE POWER FAULT. A SELF-TEST WAS COMPLETED AGAIN AND THE ALARM STAYED. THE ALARM WAS THEN MANUALLY CLEARED BY THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR AT 11:18 AM, AND THE ALARM DID NOT RETURN UNTIL 11:50 AM. EVENT LOG FILES FROM THE NEWER CONTROLLER RECORDED A DRIVELINE POWER FAULT ALARM ASSOCIATED WITH AN (F5) PWR_B_BROKEN FAULT FLAG. TECHNICAL SERVICES SUGGESTED THAT THE ORIGINAL MODULAR CABLE'S DAMAGE ALONG WITH THE DATA FROM BOTH SYSTEM CONTROLLERS MAY HAVE BEEN INDICATIVE OF A POOR CONNECTION WITH THE SUPERIOR MODULAR CABLE CONNECTION DUE TO FLUID INGRESS, AS NO DAMAGE TO THE CONDUCTORS WAS SUSPECTED. ON 31JUL2023 THE SUPERIOR MODULAR CABLE CONNECTION OF THE NEWER MODULAR CABLE WAS CLEANED AND NO ADDITIONAL ALARMS WERE SEEN. RELATED MANUFACTURER REPORT NUMBER FOR THE DRIVELINE FAULTS AND FLUID INGRESS ON THE PUMP: 2916596-2023-05829 RELATED MANUFACTURER REPORT NUMBER FOR THE CONTROLLER DAMAGE: 2916596-2023-06294 RELATED MANUFACTURER REPORT NUMBER FOR THE FLUID INGRESS AND DAMAGE ON THE ORIGINAL MODULAR CABLE: 2916596-2023-05830.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283260 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8854654 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male