BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 17311568 · Received July 12, 2023

    Report

    Report Number
    2916596-2023-04596
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 21, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER BEING UNABLE TO TRANSFER DATA TO THE SYSTEM MONITOR POTENTIALLY DUE TO A DAMAGED WHITE POWER CABLE WAS UNABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: HSC-101688) WAS NOT RETURNED FOR ANALYSIS AND NO LOG FILES NOR IMAGES WERE SUBMITTED FOR REVIEW. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: HSC-101688) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ EXPLAINS HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL ALARMS AND ALSO CONTAIN A SUBSECTION ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿. THIS SECTION INFORMS THE USER TO CHECK THE SYSTEM CONTROLLER POWER CABLES FOR TWISTING, KINKING, OR BENDING WHICH COULD CAUSE DAMAGE TO THE WIRES INSIDE. THIS SECTION INFORMS THE USER NOT TO ¿TWIST, KINK, OR SHARPLY BEND THE SYSTEM CONTROLLER POWER CABLES¿ AND STATES, ¿IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN¿. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 6 ¿ ¿CARING FOR EQUIPMENT¿ EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT. HEARTMATE 3 PATIENT HANDBOOK (REV. D) AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) CAUTION 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTROLLER WAS NOT TRANSFERRING DATA TO THE HEARTMATE TOUCH. THE PROBLEM PERSISTED WHEN THE HEARTMATE TOUCH WAS EXCHANGED FOR A SYSTEM MONITOR. MANIPULATION OF THE WHITE POWER CABLE REVEALED INTERMITTENT DATA TRANSFER. SOME DAMAGE TO THE WHITE POWER CABLE BEND RELIEF WAS NOTED EXTERNALLY. THE CONTROLLER WAS EXCHANGED, BUT IT WAS UNKNOWN IF THE DATA TRANSFER ISSUE HAD RESOLVED AS THE PATIENT HAD NOT RETURNED TO THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241060 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7945783 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male