BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP TUBING

    MDR report key: 2873025 · Received December 13, 2012

    Report

    Report Number
    3005168196-2012-00426
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE TUBING ASSEMBLY IS COMPLETE AND WITHOUT ANY VISIBLE DAMAGE. THE LURE FITTINGS THAT ARE PART OF THIS ASSEMBLY WERE TESTED IN THE STATE THEY WERE RETURNED IN, NO TIGHTENING OR OTHER ADJUSTMENTS WERE PREFORMED. THE BLUE COUPLING WAS ATTACHED TO AN EXAMPLE PUMP AND CANISTER AND THE PUMP WAS TURNED ON. THE VACUUM STABILIZED AT -24.5 IN HG WITH THE FLOW SWITCH IN THE ON POSITION. WITH THE SWITCH IN THE OFF POSITION THE PRESSURE MEASURED -27.0 IN HG. WHEN THE CANISTER WAS DISCONNECTED FROM THE TUBING AND THE INLET WAS BLOCKED THE VACUUM MEASURE -27.0 IN HG. THE TUBING IS FULLY FUNCTIONAL AND SHOWS NO LEAKS. CONCLUSION: THE LOSS OF VACUUM PRESSURE NOTED IN THE COMPLAINT COULD NOT BE DUPLICATED DURING OUR TESTING. SINCE THE PRODUCT IS MADE UP OF A SERIES OF LURE FITTING EQUIPPED PIECES, IT IS POSSIBLE THAT WHILE IN USE ONE OR MORE OF THE LURE FITTINGS WERE LOOSENED, CAUSING THE LACK OF VACUUM NOTED. HOWEVER, NONE OF THE FITTINGS WERE LOOSE WHEN IT WAS RETURNED THEREFORE IT IS UNKNOWN IF THE FITTINGS WERE TIGHTENED AFTER THE CASE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PHYSICIAN PERFORMED THROMBECTOMY IN THE LEFT M1 SEGMENT OF THE PATIENT WITH ACUTE CEREBRAL INFARCTION. DURING ASPIRATION, THE PHYSICIAN FELT STRANGENESS HE DIDN'T USUALLY HAVE. IN CHECKING AROUND, HE FOUND IT WAS WEAKNESS IN ASPIRATION SEEMED TO BE CAUSED BY AIR LEAKAGE FROM SOME PART. THE PHYSICIAN INVESTIGATED EACH Y CONNECTER AND T SHAPE STOPCOCK WITH NO PROBLEM, BUT THE JOINT CONNECTING THE ASPIRATION TUBING AND SLIDER PART WITH AIR LEAKAGE. HE FINISHED THE PROCEDURE WITH ANOTHER NEW PST-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM ASPIRATION PUMP TUBING NRY NRY PENUMBRA, INC. F26453

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR