BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 18154552 · Received November 16, 2023

    Report

    Report Number
    2916596-2023-08043
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    January 18, 2022
    Report Date
    June 4, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1 BRAND NAME: CORRECTED. SECTION D4 CATALOG NUMBER: CORRECTED. SECTION D4 PRIMARY UDI NUMBER: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: FLUID INGRESS IN POWER CABLE THE REPORTED EVENT OF A COMMUNICATION ISSUE BETWEEN THE SYSTEM CONTROLLER AND HEARTMATE TOUCH DUE TO IRREPARABLE DAMAGE WAS CONFIRMED VIA THE SUBMITTED PHOTO. SYSTEM CONTROLLER, SERIAL HSC-091690, WAS NOT RETURNED FOR ANALYSIS. THE PROVIDED INFORMATION INDICATED THAT MULTIPLE ATTEMPTS WITH DIFFERENT HEARTMATE TOUCH DEVICES WERE ATTEMPTED. THE SUBMITTED PICTURE SHOWS A DAMAGED WHITE POWER CABLE JACKET IN TWO LOCATIONS. ONE OF THE DAMAGE LOCATIONS IS INSIDE THE STRAIN RELIEF WHICH IS BROKEN OFF. THE ORANGE TRANSMISSION WIRE, RESPONSIBLE FOR SENDING DATA TO THE MONITOR, WAS OBSERVED TO BE SEVERED WHICH WOULD CAUSE A COMMUNICATION ISSUE BETWEEN THE SYSTEM CONTROLLER AND A MONITOR. IT IS UNCLEAR IF THERE IS ANY DAMAGE TO THE REMAINING OF THE UNDERLYING WIRES. THE ROOT CAUSE FOR THE COMMUNICATION ISSUE WAS A SEVERED TRANSMISSION WIRE; HOWEVER, A ROOT CAUSE FOR THE DAMAGE WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8-¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6-¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY TAKE CARE AND MAINTAIN THE INTEGRITY OF THE SYSTEM CONTROLLER. 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 REPORTED THE PRIMARY CONTROLLER WOULD NOT COMMUNICATE WITH THE HEARTMATE TOUCH. MULTIPLE ATTEMPTS WITH DIFFERENT HEARTMATE TOUCH DEVICES WERE ATTEMPTED.

    Description of Event or Problem · 0

    THE SYSTEM CONTROLLER WAS EXCHANGED DUE TO IRREPARABLE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981027 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7765883 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male