BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF

    MDR report key: 17654848 · Received August 30, 2023

    Report

    Report Number
    2916596-2023-06113
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 11, 2023
    Report Date
    May 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013266
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    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 OUTFLOW GRAFT WAS RETURNED IN LIKE-NEW CONDITION. VISUAL INSPECTION OF THE OUTFLOW GRAFT REVEALED THE SURFACE OF THE KNITTED GRAFT APPEARED SHINY, INDICATING THAT GELATIN WAS PRESENT IN THE GRAFT. NO HOLES OR DAMAGE WERE OBSERVED THROUGH VISUAL OR MICROSCOPIC INSPECTION. THE OUTFLOW GRAFT WAS PLUGGED, AND THE LUMEN WAS FILLED WITH WATER. THE GRAFT HELD WATER UNTIL THE WATER PRESSURE WAS DIRECTED TOWARD THE HARDWARE CONNECTION THEN WATER BEGAN TO DRIP FROM THE SPOT WHERE THE GRAFT MATERIAL MEETS THE METAL, REPRODUCING THE LEAK. THE REMAINDER OF THE GRAFT DID NOT LEAK. THE GRAFT WAS SENT TO PLEASANTON FOR ADDITIONAL TESTING. A MANUFACTURING ANALYSIS TASK WAS INITIATED TO ADDRESS THE OUT OF BOX LEAKING OF THE OUTFLOW GRAFT DURING PUMP ASSEMBLY. ROOT CAUSE ANALYSIS FOUND THAT THE MOST PROBABLE ROOT CAUSE OF THE LEAKING GRAFT WAS RELATED TO THE STITCHING METHOD AT THE SUPPLIER. AN EXTERNAL CORRECTIVE ACTION WAS ISSUED TO THE SUPPLIER. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE OUTFLOW GRAFT, LOT # 8897046, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) REV. C IS CURRENTLY AVAILABLE. SECTION 5 OF THIS IFU CONTAINS INSTRUCTIONS FOR UNPACKING AND PREPARING THE SEALED OUTFLOW GRAFT. SECTION 5 ALSO STATES THAT DURING THE IMPLANT PROCESS, A COMPLETE BACKUP SYSTEM (IMPLANT KIT AND EXTERNAL COMPONENTS) MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PUMP PREP AFTER THE OUTFLOW GRAFT WAS ATTACHED, IT WAS NOTICED THAT THERE WAS LEAKING AT THE POINT OF CONNECTION WHERE THE DACRON MET THE METAL. THE OUTFLOW GRAFT WAS REMOVED AND REPLACED. THE LEAKING OCCURRED AGAIN. ANOTHER OUTFLOW GRAFT WAS OPENED AND ATTACHED WHICH LEAKED AS WELL. A THIRD OUTFLOW GRAFT WAS OPENED AND THIS TIME IT DID NOT LEAK. RELATED MFR # 2916596-2023-06114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491879 HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 105581US 8897046 00813024013266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown