BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 15463009 · Received September 22, 2022

    Report

    Report Number
    2916596-2022-13620
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    September 4, 2022
    Report Date
    September 28, 2022
    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

    RELATED MFR # 2916596-2022-13619. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT WAS CONFIRMED VIA THE LOG FILE REVIEW AND WAS REPRODUCED ON THE RETURNED MODULAR CABLE, LOT 190294 WHICH IS INVESTIGATED UNDER MFR # 2916596-2022-13619. THE LOG FILE SPANNED APPROXIMATELY 5 DAYS (B)(6) 2022 TO (B)(6) 2022 PER THE TIMESTAMP). DRIVELINE POWER FAULT ALARM ACTIVATED ON (B)(6) 2022 AT 21:45 DUE TO BROKEN POWER A. THE ALARM CONTINUED ACTIVATE THROUGH THE END OF THE LOG FILE DESPITE SHOWING NO CONTROLLER FAULT FLAG. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED LIMIT. NO OTHER NOTABLE ALARM WAS OBSERVED. THE LOG FILE FROM NEW CONTROLLER, SERIAL (B)(6), FOLLOWING THE MOD CABLE EXCHANGE SPANNED APPROXIMATELY 1 DAYS (B)(6) 2022 TO (B)(6) 2022 PER THE TIMESTAMP). NO ADDITIONAL DRIVELINE POWER FAULT ALARM WAS OBSERVED. THE HM3 SYSTEM CONTROLLER, SERIAL (B)(6) , WAS NOT RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE MODULAR CABLE AND NOT AN ISSUE WITH THE CONTROLLER. 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 III INSTRUCTIONS FOR USE SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALARMS INCLUDING DRIVELINE POWER FAULT. 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 A DAMAGED MODULAR CABLE. THE LOG FILES CAPTURED A DRIVELINE POWER FAULT ON (B)(6) 2022 AT 21:40:27. THIS DAMAGE WAS LIKELY DUE TO AN ISSUE WITH THE MODULAR CABLE. THE DEVICE FUNCTION WAS NOT AFFECTED BY THIS EVENT. THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED AND THE ALARM HAD NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2695325 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 Female