BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 18579887 · Received January 25, 2024

    Report

    Report Number
    2916596-2024-00589
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    January 8, 2024
    Report Date
    April 29, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE COMMUNICATION FAULT ALARMS WAS CONFIRMED VIA LOG FILE ANALYSIS; HOWEVER, WAS UNABLE TO BE REPRODUCED DURING TESTING. A REVIEW OF THE EVENT LOG FILE, EXTRACTED FROM HSC-(B)(6) CONTAINED DATA SPANNING APPROXIMATELY 10 DAYS (B)(6)2023 ¿ (B)(6) 2024 PER TIMESTAMP). ON (B)(6) 2024 AT 9:19:00, A COM B FAULT ACTIVATED. AT 9:19:10, A DRIVELINE COMMUNICATION FAULT ALARM WAS TRIGGERED BY THE COM B FAULT. THE ALARM WAS ACTIVE THROUGHOUT THE REMAINDER OF THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED. THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 8894604) WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE INLINE CONNECTOR REVEALED CORROSION AT THE BASE OF THE PINS. THE MODULAR CABLE WAS CONNECTED AND FUNCTIONALLY TESTED WITH THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER AND WAS FOUND TO OPERATE AS INTENDED. THE MODULAR CABLE WAS ABLE TO OPERATE A PUMP WITH NO ALARMS ACTIVE. THE MODULAR CABLE¿S INNER WIRES WERE EVALUATED BUT DID NOT PASS TESTING DUE TO THE AMOUNT OF CORROSION IN THE INLINE CONNECTOR. THE CORROSION IS CONSISTENT WITH FLUID INGRESS. THE CONNECTOR WAS CLEANED, THE MODULAR CABLE WAS RETESTED AND PASSED WITHOUT ISSUE. DRIVELINE COMMUNICATION FAULT ALARMS WERE UNABLE TO BE REPRODUCED THROUGHOUT TESTING. ALTHOUGH THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED, THE OBSERVED CORROSION WITHIN THE MODULAR CABLE¿S INLINE CONNECTOR HAD THE POTENTIAL TO HAVE RESULTED IN THE REPORTED ALARM. ACCORDING TO THE ACCOUNT, THE PATIENT HAS A RECENT HISTORY OF UNPLUGGING THEIR DRIVELINE TO TAKE SHOWERS. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. C SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK, REV. D, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING DRIVELINE FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. C, SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK, REV. D, SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE AND ADVISES THE PATIENT NOT TO GET THEIR EQUIPMENT WET. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. C, AND PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. THE IFU AND PATIENT HANDBOOK CONTAINS INFORMATION ON CARING FOR THE DRIVELINE IN SECTION 4 ¿LIVING WITH THE HEARTMATE 3". IN SEVERAL SECTIONS, THIS DOCUMENT WARNS THE USER TO NEVER PUT THE DRIVELINE, SYSTEM CONTROLLER, OR ANY EXTERNAL EQUIPMENT INTO WATER OR LIQUID; IMMERSION IN WATER OR LIQUID MAY CAUSE THE PUMP TO STOP. SECTION 4 "LIVING WITH THE HEARTMATE 3" OF THE PATIENT HANDBOOK (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. 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. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MFR# 2916596-2024-00273 AND RELATED MFR # 2916596-2024-00590 IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC ON 08-JAN-2024 WITH A DRIVELINE COMMUNICATION FAULT. THE PATIENT HAD A HISTORY OF DISCONNECTING THEIR DRIVELINE BUT HASN'T DONE IT LATELY. A REVIEW OF THE LOG FILE REVEALED DRIVELINE COMMUNICATION FAULT ALARMS ON 08-JAN-2024. THE PATIENT'S SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED ON 08-JAN-2024. ON 10-JAN-2024, THE DRIVELINE COMMUNICATION FAULTS RETURNED ON THE PATIENT'S NEW CONTROLLER. THE DRIVELINE CONNECTOR WAS CLEANED ON 11-JAN-2024 AND THE MODULAR CABLE WAS REPLACED AFTER THE CLEANING. THE ALARMS DID NOT RETURN AFTER THE CONNECTOR CLEANING.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD A HISTORY OF UNPLUGGING THE DRIVELINE TO TAKE SHOWERS. WATER DAMAGE WAS NOTED ON THE PUMP CABLE FOLLOWING THE SYSTEM CONTROLLER AND MODULAR CABLE EXCHANGES. THE DRIVELINE COMMUNICATION FAULT ALARMS DID NOT RETURN AFTER THE PUMP CABLE CONNECTOR CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173316 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8894604 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male