BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V

    MDR report key: 5855283 · Received August 8, 2016

    Report

    Report Number
    3005168196-2016-01151
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    July 11, 2016
    Report Date
    July 11, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    UDI-DI
    00814548012773
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THERE WAS NO VISIBLE DAMAGE TO THE EXTERIOR OF THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PUMP MAX WAS FUNCTIONAL. THE PUMP MAX WAS PLUGGED IN AND POWERED ON AND GENERATED VACUUM. IF THE PUMP MAX IS USED TO GENERATE VACUUM AND THEN TURNED OFF, IT MAY HAVE TO RETURN TO EQUILIBRIUM WITH ATMOSPHERIC PRESSURE BEFORE IT CAN GENERATE VACUUM AGAIN. IT IS LIKELY THAT INITIAL ATTEMPTS TO TURN THE PUMP MAX ON THAT WERE REPORTED AS UNSUCCESSFUL CAUSED THE PUMP MAX TO GENERATE VACUUM. ADDITIONAL IMMEDIATE ATTEMPTS TO TURN THE PUMP MAX ON WERE LIKELY UNSUCCESSFUL DUE TO THE PUMP MAX BEING UNDER VACUUM. IT IS LIKELY THAT THE TIME IT TOOK TO TROUBLESHOOT THE PUMP MAX BY THE HOSPITAL STAFF ALLOWED THE PUMP MAX VACUUM PRESSURE TO RETURN TO EQUILIBRIUM WITH ATMOSPHERIC PRESSURE, AFTER WHICH IT WAS ABLE TO BE SUCCESSFULLY SWITCHED ON. PENUMBRA PUMPS ARE 100% 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 IN THE INFERIOR VENA CAVA (IVC) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). DURING THE PROCEDURE, AFTER THE PUMP MAX WAS SUCCESSFULLY USED FOR THE FIRST PASS, THE NURSE MADE THREE ATTEMPTS TO TURN THE PUMP MAX ON FOR THE SECOND PASS BUT DID NOT COMPLETELY DEPRESS THE "ON" BUTTON ON ANY OF THE ATTEMPTS. THEREFORE, ON EACH OF THE THREE ATTEMPTS, THE PUMP MAX WOULD TURN ON BUT WOULD NOT STAY ON. IT WAS REPORTED THAT THE NURSE WAS STANDING BEHIND THE PUMP MAX AND REACHING OVER IT EACH TIME TO TURN IT ON. AFTER THE THIRD ATTEMPT, THE NURSE MOVED THE PUMP MAX SO THAT SHE COULD TURN IT ON FROM THE FRONT AND WAS ABLE TO FULLY DEPRESS THE "ON" BUTTON; HOWEVER, THE PUMP MAX DID NOT TURN ON AND WAS THEREFORE, UNPLUGGED. AFTER BEING UNPLUGGED, THE PUMP MAX WAS RESTARTED AND THE "ON" SWITCH WAS COMPLETELY PUSHED. THE PROCEDURE WAS THEN COMPLETED USING THE SAME PUMP MAX, AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505857 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX JCX PENUMBRA, INC. F22845-10 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR