BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 18830947 · Received March 4, 2024

    Report

    Report Number
    2916596-2024-01324
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 14, 2023
    Report Date
    May 28, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    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

    VOLUNTARY MEDWATCH NUMBER 3400300000-2022-0000007 WAS RECEIVED ON 26FEB2024. SECTIONS A1 AND A2: PATIENT INFORMATION WAS MISSING. INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION A2: CORRECTED, SECTIONS D1 AND D4: CORRECTED, SECTION G2: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A TORN WHITE POWER LEAD AND SEVERELY BENT AND COILED POWER CABLES WAS UNABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (S/N: HSC-103416) WAS NOT RETURNED FOR ANALYSIS. PER THE PROVIDED INFORMATION, THE SYSTEM CONTROLLER WAS REPLACED. NO PHOTOS, LOG FILES, OR ADDITIONAL DOCUMENTS WERE SUBMITTED FOR REVIEW. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE HEARTMATE 3 INSTRUCTIONS FOR USE (SECTION 2 ¿SYSTEM OPERATIONS") PROVIDES INSTRUCTIONS FOR REPLACING THE SYSTEM CONTROLLER. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) COVERS ALL ALARMS (VISUAL AND AUDIBLE), AND THE ACTIONS TO TAKE IF THE ALARM CANNOT BE RESOLVED. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 6 ¿CARING FOR THE EQUIPMENT¿) DESCRIBES HOW TO PROPERLY CARE FOR ALL HEARTMATE EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER AND ITS POWER CABLES. THE PATIENT HANDBOOK CAUTIONS 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

    IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE CLINIC ON (B)(6) 2024 WITH A TORN WHITE POWER LEAD CABLE ON THE SYSTEM CONTROLLER. BOTH POWER CABLES WERE SEVERELY BENT AND COILED. THE SYSTEM CONTROLLER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160690 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8028041

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention