BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 11588588 · Received March 30, 2021

    Report

    Report Number
    2916596-2021-01490
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 10, 2021
    Report Date
    June 23, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE COMMUNICATION FAULT WAS CONFIRMED VIA THE LOG FILES. A REVIEW OF THE LOG FILES SPANNED APPROXIMATELY 2 DAYS ((B)(6) 2021 PER TIME STAMP). THE DRIVELINE COMM FAULT ALARM WAS ACTIVE THROUGHOUT THE ENTIRE LOG FILE. THE INITIAL ACTIVATION OF THE ALARM WAS OVERRIDDEN BY NEW EVENTS. THE COM A FAULT WAS ACTIVE ON (B)(6) 2021 AT 13:52 JUST BEFORE THE DRIVELINE WAS DISCONNECTED FOR A CONTROLLER EXCHANGE. THIS ALARM WAS NOT ASSOCIATED WITH ANY MOTOR SPEED, CALCULATED AVERAGE FLOW, OR CALCULATED AVERAGE PI CHANGES. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. THE RETURNED MODULAR CABLE, LOT 7082731, WAS TESTED WITH THE RETURNED CONTROLLER AND NO ALARMS WERE PRODUCED. THE CABLES INTERNAL CONDUCTORS WERE ALSO TESTED AND NO ANOMALIES WERE NOTED. THE CABLE WAS FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED DURING ANALYSIS. THE PROVIDED INFORMATION INDICATED THAT EXCHANGING THE CONTROLLER AND MODULAR CABLE RESOLVED THE DRIVELINE COMMUNICATION FAULT ALARM. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. INCIDENTAL FINDINGS: DEBRIS IN CONNECTOR. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE 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 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT DRIVELINE COMMUNICATION FAULT ALARMS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RELATED MANUFACTURER'S REPORT # 2916596-2021-01489. IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE COMMUNICATION FAULT. NO OTHER ALARMS NOTED ON INTERROGATION. UPON ANALYSIS OF THE EVENT LOG FILE, TECHNICAL SERVICES NOTED DRIVELINE COMMUNICATION FAULT ALARMS ON (B)(6) 2021. IT WAS REPORTED THAT THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED AND THE ALARM CONDITION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487843 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525 7082731

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR