BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V

    MDR report key: 6859296 · Received September 12, 2017

    Report

    Report Number
    3005168196-2017-01575
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 16, 2017
    Report Date
    August 21, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    UDI-DI
    00814548012773
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THERE WAS CORROSION INSIDE THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX) OUTLET PISTON CROWN. CONCLUSION: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PUMP MAX WAS NONFUNCTIONAL. THE PUMP MAX WAS PLUGGED IN AND POWERED ON AND NO VACUUM WAS OBSERVED. THEREFORE, THE PUMP MAX WAS NONFUNCTIONAL. DURING FURTHER EVALUATION OF THE RETURNED DEVICE, THE PUMP MAX HOUSING WAS OPENED BY THE PENUMBRA INVESTIGATOR AND CORROSION WAS OBSERVED AROUND THE INLET CROWN PISTON. THE CORROSION INSIDE THE PUMP MAX LIKELY CAUSED THE PUMP MAX TO SEIZE UP AND PREVENT THE PUMP MAX FROM PRODUCING VACUUM DURING THE PROCEDURE. PENUMBRA PUMPS ARE VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING INCOMING INSPECTION BY QUALITY. 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 THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN CONNECTED THE PUMP MAX TO A PENUMBRA ASPIRATION TUBING (TUBING) AND A PENUMBRA PUMP MAX CANISTER (CANISTER), AND POWERED ON THE PUMP MAX; HOWEVER, NO VACUUM WAS PRODUCED EVEN THOUGH THE VACUUM REGULATOR KNOB WAS TURNED FULLY. THEREFORE, THE PUMP MAX WAS DISCONNECTED AND THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638007 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX JCX PENUMBRA, INC. F19963-10 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1