BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 14471274 · Received May 23, 2022

    Report

    Report Number
    2916596-2022-10967
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    August 18, 2021
    Report Date
    June 1, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER WAS REQUESTED, BUT NOT YET PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MEDWATCH / USER FACILITY REPORT # 3400300000-2021-0000026 WAS RECEIVED ON 06MAY2022. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF "SIGNIFICANT BEND" IN THE BLACK POWER CABLE OF THE SYSTEM CONTROLLER WAS NOT CONFIRMED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION (INCLUDING THE SERIAL NUMBER OF THE SYSTEM CONTROLLER, IF PRODUCT WOULD BE RETURNED TO ABBOTT FOR EVALUATION, AND IF PICTURES OF THE REPORTED DAMAGE COULD BE PROVIDED); HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE SERIAL NUMBER OF THE PRODUCT IS UNKNOWN. 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¿ CONTAIN A SUBSECTION ENTITLED "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 PATIENT HANDBOOK (REV. D) SECTION 6 "CARING FOR THE EQUIPMENT" AND HEARTMATE 3 IFU (REV. C) SECTION 8 "EQUIPMENT STORAGE AND CARE" DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 10 AND HEARTMATE 3 IFU (REV. C) SECTION F, BOTH ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. 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.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH RECEIVED THAT STATES THE PATIENT HAD A SIGNIFICANT BEND IN THEIR CONTROLLER POWER CABLE DOWN TO THE BLACK CONNECTOR. THE POWER CABLE WAS MANIPULATED, BUT THIS DID NOT CORRECT THE ISSUE. THE CONTROLLER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543369 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male