BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 15463046 · Received September 22, 2022

    Report

    Report Number
    2916596-2022-13619
    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
    00813024013181
    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

    PATIENT AGE AND WEIGHT REQUESTED BUT NO PROVIDED. RELATED MFR # 2916596-2022-13620. 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. THE LOG FILE SPANNED APPROXIMATELY 5 DAYS (31AUG2022 TO 05SEP2022 PER THE TIMESTAMP). DRIVELINE POWER FAULT ALARM ACTIVATED ON 04SEP2022 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), SPANNED APPROXIMATELY 1 DAYS (05SEP2022 TO 06SEP2022 PER THE TIMESTAMP). NO ADDITIONAL DRIVELINE POWER FAULT ALARM WAS OBSERVED. VISUAL INSPECTION OF THE RETURNED MODULAR CABLE, LOT 190294, REVEALED MULTIPLE RESCUE TAPES. THE CABLE WITH THE RESCUE TAPES WAS OPERATED ON A MOCK CIRCULATORY LOOP AND NO ALARM WAS REPRODUCED. THE INTEGRITY OF THE INTERNAL WIRES OF THE MODULAR CABLE WAS TESTED WHICH PASSED WITHOUT ANY ISSUE. THE CABLE WAS STRIPPED DOWN TO THE WIRE REVEALING A SEVERED WIRE ALONG WITH DAMAGED WIRES INSULATOR. THE CABLE WAS RECONNECTED TO THE MOCK LOOP AND REPRODUCED DRIVELINE POWER FAULT ALARM. A ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE DAMAGED WIRES. 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. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ ¿CARING FOR EQUIPMENT¿ EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT, INCLUDING THE MODULAR CABLE. 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
    2694364 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 190294 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 Female