BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

    MDR report key: 4851612 · Received June 17, 2015

    Report

    Report Number
    3005168196-2015-00579
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 18, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THERE WAS NO VISIBLE DAMAGE TO THE EXTERIOR OF THE PUMP. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT EVEN THOUGH THE GREEN LIGHT OF THE POWER BUTTON WAS ON, THE PUMP ITSELF WOULD NOT WORK AT ALL. THE PUMP WAS TESTED BEFORE THE PROCEDURE AND DID NOT WORK, SO THE PATIENT WAS TREATED BY A SYRINGE ASPIRATION. EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE COMPLAINT. THE PUMP WAS POWERED ON AND WORKED; HOWEVER, THE VACUUM PRESSURE COULD NOT BE ADJUSTED. THE REGULATOR KNOB WAS DAMAGED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE DETERMINED. PENUMBRA SUPPLIER QUALITY HAS BEEN NOTIFIED. THESE DEVICES ARE 100% FUNCTIONALLY TESTED DURING INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS

    Additional Manufacturer Narrative · 1

    CORRECTION TO EVENT DATE: (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FROM THE SUPPLIER ARE AS FOLLOWS: RESULTS: THE DEVICE WAS OPENED TO DETERMINE IF THE ROUTING OF THE WIRING AND TUBE ASSEMBLY CONNECTIONS WERE SECURED AS INTENDED. DURING THE REVIEW, IT WAS OBSERVED THAT THE VACUUM TUBE ATTACHED TO THE NEEDLE VALVE PORT WAS TWISTED (KINKED). THE KINKED TUBE WOULD HAVE CONTRIBUTED TO THE VACUUM GAUGE NOT BEING ABLE TO ADJUST. VACUUM PUMP TUBE WAS UNKINKED BY ROTATING THE BODY OF THE REGULATOR KNOB. VACUUM TUBE WAS STRAIGHTENED TO PREVENT ANY BLOCKAGE OF AIR. THE TOP HOUSING WAS PLACED BACK ONTO THE BOTTOM HOUSING AND RESTARTED. WHILE THE ASPIRATION PUMP WAS POWERED ON, THE VACUUM PRESSURE GAUGE WAS ABLE TO BE ADJUSTED WHILE THE REGULATOR KNOB WAS BEING ROTATED. CONCLUSIONS: BASED ON THE INVESTIGATION, IT CAN BE CONCLUDED THAT THE KINK IN THE VACUUM TUBE PREVENTED THE PRESSURE IN THE VACUUM GAUGE FROM BEING ADJUSTED. IN ADDITION, IT SHALL BE NOTED THAT OVER-ROTATING THE REGULATOR KNOB BEYOND THE MAXIMUM SET POINT COULD INTRODUCE A KINK IN THE VACUUM TUBE LINE. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR. THE SUPPLIER REVIEWED THE WORK ORDER AND CONCLUDED THAT THE MANUFACTURING OF ASPIRATION PUMPS WERE MANUFACTURED IN ACCORDANCE WITH MANUFACTURING PROCEDURES. A 100% INSPECTION WAS PERFORMED ON UNITS RETURNED TO THE SUPPLIER FOR INVESTIGATION AND REVEALED THAT ALL REGULATOR KNOBS WERE SECURED TO THE HOUSING AND DISPLAYED NO ANOMALIES.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220. DURING THE PROCEDURE, THE PUMP MAX 220 WOULD NOT CREATE A VACUUM. THE PROCEDURE CONTINUED USING A SYRINGE AND MANUAL ASPIRATION AND THE VESSEL WAS SUCCESSFULLY PARTIALLY RECANALIZED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393273 PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 JCX JCX PENUMBRA, INC. F19958-26

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR