BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 10733865 · Received October 26, 2020

    Report

    Report Number
    2916596-2020-05070
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 29, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: INVESTIGATION OF (B)(4) CONFIRMED A CURRENT SENSE ISSUE. THE PUMP WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 6.5¿ FROM THE PUMP HOUSING, AND THE SEVERED PORTION AND MODULAR CABLE WERE NOT RETURNED. THE APICAL CUFF WAS RETURNED PROPERLY ENGAGED WITH THE CUFF LOCK. THE SEALED OUTFLOW GRAFT CONDUIT WITH BEND RELIEF WAS RETURNED ATTACHED TO THE PUMP OUTLET PORT. AN ADDITIONAL PORTION OF THE SEALED OUTFLOW GRAFT APPROXIMATELY 6¿ LONG WAS ALSO RETURNED. THE PUMP APPEARED TO HAVE BEEN EXPOSED TO A FIXATIVE PRIOR TO RETURN. EXAMINATION OF THE INFLOW CANNULA REVEALED A BIOLOGICAL LINING ALONG THE PROXIMAL OPENING. THE DEPOSITION WAS STRONGLY ADHERED AND DID NOT APPEAR TO OBSTRUCT THE BLOOD PATHWAY. VISUAL INSPECTION OF THE OUTFLOW CANNULA DID NOT REVEAL ANY LAMINATED OR DENATURED DEPOSITIONS, OR THROMBUS FORMATIONS. UPON DISASSEMBLY OF THE PUMP BODY, EXAMINATION OF THE BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF DEVELOPED, OR ADHERED DEPOSITIONS, OR THROMBUS FORMATIONS. VISUAL INSPECTION OF THE PUMP ROTOR, AND ROTOR WELL DID NOT REVEAL ANY SURFACE SCRATCHES OF DEFECTS. THE LVAD EVENT LOG FILE (CS-143312 99240909_L3E) CONTAINED DATA FROM 12JUN2019 20:08:15 THROUGH 12JUN2019 21:40:24 ,AND THE LVAD PERIODIC LOG FILE (CS-143312 99240909_L3P) CONTAINED DATA FROM 02JUN2019 06:45:04 THROUGH 12JUN2019 20:53:07. THROUGHOUT BOTH LOG FILES, THE CURRENT SENSE VALUES CAPTURED APPEARED ELEVATED AND WAS LOCKED AT 440MA, HOWEVER, BOTH LOG FILES APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED. (B)(4) WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    DURING THE PRODUCT PERFORMANCE ENGINEER'S ANALYSIS ON 06OCT2020 INVESTIGATION OF THE RETURNED HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), CONFIRMED A CURRENT SENSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200542 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 6006469

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR