BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V

    MDR report key: 6200194 · Received December 22, 2016

    Report

    Report Number
    3005168196-2016-01886
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 2, 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 220 (PUMP) WAS FOUND TO HAVE TWO BLOWN FUSES PRIOR TO POWERING ON THE PUMP. WHEN PLUGGING THE PUMP IN, THERE WAS A SPARK AND A BUZZING SOUND. THE FUSE IN OUR STEP UP TRANSFORMER WAS BLOWN. THE ELECTRICAL SOCKET WAS FOUND TO HAVE BEEN BURNT AND SHOWS BURNS TO THE BOTTOM OF THE PUMP. UPON OPENING THE PUMP, THE VACUUM PISTONS WERE FOUND TO BE CORRODED. THE BACK OF THE PUMP SHOWS THE VENT GRILL BROKEN OUTWARDS. THE INSIDE OF THE PUMP HOUSING SHOWS SIGNS OF CARBON AND DUST RESIDUE. RUST WAS FOUND ON THE PUMP CHASSIS NEAR THE ELECTRICAL OUTLET. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT AN ELECTRICAL SPARK OCCURRED ONCE THE PUMP MAX WAS CONNECTED TO A LIVE POWER SOURCE. PRIOR TO CONNECTING THE PUMP MAX, A PENUMBRA INVESTIGATOR CONFIRMED THAT BOTH FUSES IN PUMP MAX WERE BLOWN, AND THAT THE DEVICE ON/OFF SWITCH WAS IN THE OFF POSITION. FURTHER EVALUATION REVEALED CORROSION BOTH ON THE BASE PLATE, AS WELL AS INSIDE BOTH CYLINDERS OF THE VACUUM PUMP. SIGNS OF CORROSION WERE ALSO OBSERVED ON THE BRASS FITTINGS INSIDE THE PUMP HOUSING. IT IS POSTULATED THAT THE MOISTURE THAT CAUSED THE CORROSION OBSERVED INSIDE THE PUMP LIKELY CONTRIBUTED TO THE SHORT CIRCUIT AND SUBSEQUENT ARCHING INSIDE THE PUMP. THESE TYPES OF DAMAGE LIKELY OCCURRED DUE TO IMPROPER STORAGE CONDITIONS OF THE PUMP MAX. FURTHER EVALUATION REVEALED THAT THE PUMP MAX HOUSING WAS DAMAGED AND A CARBON BUILD-UP WAS PRESENT INSIDE THE PUMP HOUSING LIKELY ATTRIBUTED TO THE PRECEDING SPARKING/ARCHING. THIS FINDING FURTHER CORROBORATES THAT THE PUMP MAX WAS LIKELY IMPROPERLY STORED AND MANIPULATED. PENUMBRA PUMPS ARE VISUALLY AND FUNCTIONALLY INSPECTED DURING INCOMING QUALITY INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    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, WHILE IN USE, THE PHYSICIAN NOTICED SOME SPARKS COMING OUT THE PUMP MAX OUTLET. SUBSEQUENTLY, THE PUMP MAX STOPPED WORKING AND WAS UNABLE TO TURN ON AFTERWARD; THEREFORE, THE PROCEDURE WAS COMPLETED BY MANUAL ASPIRATION 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
    850292 PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX JCX PENUMBRA, INC. F10970-08 00814548012698

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR