BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15115079 · Received July 27, 2022

    Report

    Report Number
    2916596-2022-12200
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    July 7, 2022
    Report Date
    November 8, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) REVEALED A SLIGHT DEFORMATION TO THE PUMP OUTFLOW WASHER; HOWEVER, IT WAS CONFIRMED THAT THE WASHER WAS SEATED ENOUGH ON ALL SIDES SO AS NOT TO PROTRUDE INTO THE BLOOD FLOW PATH. THE ACCOUNT REPORTED AN ABNORMAL APPEARANCE OF THE WHITE OUTFLOW WASHER DURING DEVICE PREPARATION IN THE OPERATING ROOM. A NEW IMPLANT KIT WAS USED, AND THE AFFECTED DEVICE WAS RETURNED FOR EVALUATION. MLP-033191 WAS RETURNED ASSEMBLED, IN LIKE-NEW CONDITION, WITH THE PUMP CABLE INTACT. EXAMINATION OF THE PUMP OUTFLOW REVEALED A SLIGHT DEFORMATION TO THE OUTFLOW WASHER. FURTHER INSPECTION UNDER A MICROSCOPE CONFIRMED THE OUTFLOW WASHER WAS SEATED ENOUGH ON ALL SIDES SO AS NOT PROTRUDE INTO THE BLOOD FLOW PATH. MLP-033191 WAS REBUILT AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE DEVICE HISTORY RECORDS (DHR) ASSOCIATED WITH (B)(6) WERE REVIEWED FOR ANY DOCUMENTED NON-CONFORMANCE AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO ANOMALIES WERE FOUND AND PUMP (B)(6) PASSED THE STEPS FOR THE VISUAL INSPECTION OF OUTFLOW WASHER, PUMP COVER LEAK TEST, AND VERIFICATION THAT PTFE WASHER WAS INSTALLED AND PROPERLY SEATED. A SPECIFIC CAUSE FOR THE SLIGHT DEFORMATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION; HOWEVER, THIS FINDING WAS PREVIOUSLY INVESTIGATED AND FOUND TO BE COSMETIC ONLY. NO CORRECTIVE ACTIONS WERE RECOMMENDED. AWARENESS TRAINING WAS PERFORMED ON 27MAY2022 TO ENSURE QUALITY IS AWARE OF THE ISSUE. (B)(6) WAS MANUFACTURED ON 16MAY2022, PRIOR TO THE AWARENESS TRAINING. THE SURGICAL PROCEDURES SECTION OF HEARTMATE 3 LVAS IFU REV. C STATES TO INSPECT THE QUALITY OF THE WHITE WASHER IN THE OUTLET UNDER ¿UNPACKING THE PUMP AND ACCESSORIES TRAY.¿ THIS SECTION, UNDER ¿PREPARING, RUNNING, AND PRIMING THE PUMP,¿ ALSO STATES TO EXAMINE THE PUMP OUTFLOW CONNECTOR TO VERIFY THE PRESENCE OF THE WHITE WASHER. IF THE WHITE WASHER IS MISSING OR DAMAGED, OBTAIN ANOTHER PUMP BEFORE CONTINUING. 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 DEVICE PREPARATION IN THE OPERATING ROOM, INSPECTION OF THE DEVICE REVEALED AN ABNORMAL APPEARANCE OF THE WHITE O-RING AT THE OUTFLOW GRAFT CONNECTION POINT ON THE PUMP. THE DEVICE AND ALL COMPONENTS WERE NOT UTILIZED AND A NEW IMPLANT KIT WAS PREPARED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704073 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8476420 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female