BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 19360169 · Received May 21, 2024

    Report

    Report Number
    2916596-2024-02807
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    May 9, 2023
    Report Date
    July 30, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY REPORT: 3400300000-2022-0000025 WAS RECEIVED 02MAY2024. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION D1: CORRECTED. SECTION D4, CATALOG NUMBER, PRIMARY UID NUMBER: CORRECTED. SECTION G2: CORRECTED. SECTION H6, MEDICAL DEVICE PROBLEM CODE: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DAMAGED STRAIN RELIEFS AND MUFFLED ALARMS ON THE SYSTEM CONTROLLER WAS NOT CONFIRMED. THERE WERE NO PHOTOS OR LOG FILES SUBMITTED FOR REVIEW. SYSTEM CONTROLLER WAS NOT RETURNED FOR ANALYSIS. THE PROVIDED INFORMATION STATED THAT THE CONTROLLER WAS EXCHANGED DUE TO HAVING BOTH STRAIN RELIEFS BROKEN AND MUFFLED ALARMS. THE EXTENT OF THE STRAIN RELIEF DAMAGE AND THE CAUSE FOR THE MUFFLED ALARMS IS UNKNOWN. PER DESIGN INPUT REQUIREMENT, HEARTMATE 3 SYSTEM CONTROLLER, THE SYSTEM CONTROLLER ¿MUST PROVIDE TWO REDUNDANT ANNUNCIATORS EACH CAPABLE OF AT LEAST 85 DBA 10 CM FROM THE APERTURE¿S SURFACE¿. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING LOG FILES AND PICTURES; HOWEVER, NO RESPONSE WAS RECEIVED. A ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED DUE TO THE SERIAL NUMBER OF THE SYSTEM CONTROLLER BEING UNAVAILABLE. 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 (REV. C) SECTION 8-¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK (REV. D) SECTION 6-¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY TAKE CARE AND MAINTAIN THE INTEGRITY OF THE SYSTEM CONTROLLER CONNECTORS AND CABLES. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION B-¿TECHNICAL SPECIFICATIONS¿ EXPLAINS THAT THE CORRECT AUDIO LEVEL SPECIFICATION FOR CONTROLLER ADVISORY AND HAZARD ALARMS IS ~85 DB. 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 CLINIC WITH ALARMS MUFFLED. THE SYSTEM CONTROLLER WAS EXCHANGED.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH WAS RECEIVED THAT STATED THE PATIENT ARRIVED TO CLINIC ON (B)(6) 2023 WITH BROKEN BEND RELIEFS AND ALARMS MUFFLED. THE CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604756 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male