BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 17853460 · Received October 2, 2023

    Report

    Report Number
    2916596-2023-07165
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 11, 2023
    Report Date
    June 18, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION D1 BRAND NAME: CORRECTED , SECTION D4 MODEL NUMBER: 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: THE REPORTED EVENT OF DAMAGE TO THE MODULAR CABLE WAS NOT ABLE TO BE CONFIRMED. PROVIDED INFORMATION INDICATED THAT IT WAS PLANNED TO EXCHANGE THE HEARTMATE 3 SYSTEM CONTROLLER AND MODULAR CABLE (LOT NUMBER 7171211); HOWEVER, THE DATE FOR THE EXCHANGE WAS NOT YET SET AND NO PRODUCTS HAVE RETURNED FOR ANALYSIS. LOG FILES WERE SUBMITTED FOR REVIEW, CONTAINING APPROXIMATELY 1 DAY OF DATA ( ON (B)(6) 2023 TO (B)(6) 2023 PER THE TIMESTAMP). NO ATYPICAL EVENTS WERE OBSERVED IN RELATION TO THE MODULAR CABLE¿S PERFORMANCE. THE PUMP MAINTAINED A SPEED ABOVE THE LOW-SPEED LIMIT WITHOUT ISSUE. THE ROOT CAUSE OF THE REPORTED DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THAT THE HEARTMATE 3 MODULAR CABLE (LOT NUMBER: 7171211) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE III INSTRUCTIONS FOR USE (REV. C) SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK (REV. D) SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE TO THE MODULAR CABLE WAS NOT ABLE TO BE CONFIRMED. PROVIDED INFORMATION INDICATED THAT THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) AND MODULAR CABLE (LOT NUMBER: 7171211) WERE EXCHANGED IN NOVEMBER OF 2023; HOWEVER, THE EXCHANGED PRODUCTS WERE NOT RETURNED FOR ANALYSIS. LOG FILES WERE SUBMITTED FOR REVIEW, CONTAINING APPROXIMATELY 1 DAY OF DATA (11SEP2023 TO 12SEP2023 PER THE TIMESTAMP). NO ATYPICAL EVENTS WERE OBSERVED IN RELATION TO THE MODULAR CABLE¿S PERFORMANCE. THE PUMP MAINTAINED A SPEED WITHIN THE EXPECTED RANGE WITHOUT ISSUE. THE ROOT CAUSE OF THE REPORTED DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. HEARTMATE III INSTRUCTIONS FOR USE (IFU) SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. 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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE HEARTMATE 3 MODULAR CABLE (LOT NUMBER: 7171211) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR EVALUATION CONCERNING DAMAGE TO POWER LEAD. THE REPORTED DAMAGE TO THE POWER LEAD DOES NOT APPEAR TO BE CAUSING ANY UNUSUAL EVENTS AT THIS TIME. PATIENT¿S POWER CABLE AND MODULAR CABLE WERE DAMAGED. LOW FLOW ALARMS RESOLVED ON THEIR OWN. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS SCHEDULED TO BE CHANGED ALONG WITH MODULAR CABLE. RELATED CONTROLLER MFR# 2916596-2023-07149.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE SYSTEM CONTROLLER AND MODULAR CABLE WERE ULTIMATELY EXCHANGED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155051 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7171211 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male