BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 10955148 · Received December 5, 2020

    Report

    Report Number
    2916596-2020-05698
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    November 11, 2020
    Report Date
    April 21, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE COMMUNICATION FAULT ALARMS WAS CONFIRMED VIA LOG FILE ANALYSIS AND PRODUCT TESTING. THE HEARTMATE III MODULAR CABLE (LOT #: 190295) WAS RETURNED FOR ANALYSIS, A LOG FILE WAS SUBMITTED FOR REVIEW, AND A LOG FILE WAS DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER. THE DOWNLOADED LOG FILE AND SUBMITTED LOG FILES SPANNED APPROXIMATELY 2 DAYS ((B)(6)2020, (B)(6)2020 PER TIMESTAMP). EVENTS OCCURRING ON (B)(6) 2020 ARE FROM PRODUCT TESTING AT ABBOTT. THROUGHOUT THE LOG FILES ARE DRIVELINE COMMUNICATION FAULT ALARMS COINCIDENT WITH COM_A_FAULT ERROR CODES. THESE ALARMS CONTINUED UNTIL THE DRIVELINE WAS DISCONNECTED ON (B)(6)2020 AT 15:13:04 FOR A SYSTEM CONTROLLER EXCHANGE. THERE WERE NO OTHER NOTABLE ALARMS IN THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED. THE RETURNED MODULAR CABLE FAILED CONTINUITY TESTING AND ALARMED FOR DRIVELINE FAULT ALARMS WHEN USED IN A MOCK LOOP WITH A TEST CONTROLLER CONFIRMING THE REPORTED EVENT. THE MODULAR CABLE HAD HIGHER THAN EXPECTED RESISTANCES FOR THE INTERNAL WIRES. WHEN THE MODULAR CABLE WAS STRIPPED, SLIGHT FLUID INGRESS WAS FOUND INSIDE THE CABLE AND A KINK IN THE WIRES WAS ALSO OBSERVED. ALTHOUGH NOT CONFIRMED, THE OBSERVED FLUID INGRESS AND KINK IN THE MODULAR CABLE WIRES MAY HAVE CONTRIBUTED TO THE REPORTED DRIVELINE COMMUNICATION FAULT ALARMS. HEARTMATE III INSTRUCTIONS FOR USE (REV. C) SECTION 8 ENTITLED EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK (REV. C) SECTION 6 ¿ "CARING FOR THE EQUIPMENT" DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT. THIS SECTION ALSO EXPLAINS THE IMPORTANCE OF PROTECTING THE SYSTEM CONTROLLER CABLES FROM KINKS, SHARP BENDS, AND REPEATED BENDING. HEARTMATE III PATIENT HANDBOOK (REV. C) SECTION 10, ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE III LVAD, INCLUDING INSPECTING THE SYSTEM CONTROLLER POWER CABLES FOR DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HEARTMATE III INSTRUCTIONS FOR USE (REV. C) SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK (REV. C) SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING DRIVELINE FAULT ALARMS. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION 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 THE HEARTMATE III MODULAR CABLE (LOT #: 190295) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. 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 COMPLETE.

    Description of Event or Problem · 1

    RELATED MFR NUMBER: 2916596-2020-05699. IT WAS REPORTED THAT THE PATIENT'S DEVICE RECORDED DRIVELINE FAULTS ON (B)(6) 2020. THE ALARM CLEARED INITIALLY BUT KEPT RETURNING. THE CONTROLLER AND MODULAR CABLE WERE REPLACED AND THE ALARM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416341 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525 190295

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HEARTMATE 3 SYSTEM CONTROLLER