BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V

    MDR report key: 6043670 · Received October 20, 2016

    Report

    Report Number
    3005168196-2016-01483
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 21, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    UDI-DI
    00814548012698
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V (PUMP) WAS PLUGGED IN AND POWERED ON. THE PUMP GENERATED FULL VACUUM AND, THEREFORE, IT WAS DEEMED FUNCTIONAL. FURTHER EVALUATION REVEALED THE PLASTIC COVER FOR THE ON/OFF SWITCH WAS SEPARATED FROM THE PUMP HOUSING AND THE PISTON CROWN IN THE OUTLET CYLINDER WAS CORRODED. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PUMP WAS FUNCTIONAL. THE PUMP WAS PLUGGED IN AND POWERED ON AND GENERATED FULL VACUUM. THE PUMP HOUSING WAS REMOVED, AND THE VACUUM PUMP WAS OPENED BY PENUMBRA INVESTIGATORS. IT WAS OBSERVED THAT THE PISTON CROWN IN THE OUTLET CYLINDER WAS CORRODED. THE OBSERVED CORROSION LIKELY CAUSED THE PISTON TO SEIZE INSIDE THE CYLINDER, CAUSING THE PUMP TO GENERATE VACUUM. FURTHER EVALUATION REVEALED THE PLASTIC COVER FOR THE ON/OFF SWITCH WAS SEPARATED FROM THE PUMP HOUSING. THIS DAMAGE WAS LIKELY INCIDENTAL AND MAY HAVE OCCURRED DURING RETURN PACKAGING OR SHIPMENT. PENUMBRA PUMPS ARE FUNCTIONALLY TESTED DURING INCOMING QUALITY INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO BEGIN ASPIRATION, HOWEVER THE PUMP MAX WAS NOT PRODUCING ANY VACUUM WHEN POWERED ON. THE PHYSICIAN THEN CHANGED THE POWER CORD, HOWEVER THE PUMP MAX WAS STILL UNABLE TO PRODUCE VACUUM. THEREFORE, THE PROCEDURE WAS COMPLETED USING A SYRINGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694481 PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX JCX PENUMBRA, INC. F11347-26 00814548012698

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR