BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION TUBING

    MDR report key: 6096125 · Received November 11, 2016

    Report

    Report Number
    3005168196-2016-01605
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016221
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THERE WAS NO VISIBLE DAMAGE ON THE PART OF THE INDIGO SYSTEM ASPIRATION TUBING (TUBING) THAT WAS RETURNED FOR EVALUATION. THE RETURNED PORTION OF THE TUBING WAS CONNECTED TO A SYRINGE DURING DECONTAMINATION AND FLUID WAS ABLE TO FLOW THROUGH THE TUBING. A SYRINGE WITH JUST AIR WAS ALSO INJECTED INTO THE TUBING WITHOUT AN ISSUE. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PUMP WAS FUNCTIONAL. THE PUMP WAS PLUGGED IN AND POWERED ON AND VACUUM WAS GENERATED. THE PUMP MAY PRESENT DIFFICULTY TURNING ON WHEN UNDER VACUUM. THE VACUUM PRESSURE MAY HAVE TO DECREASE PRIOR TO RESTARTING THE PUMP. THE PUMP WAS OPENED BY THE PENUMBRA INVESTIGATOR AND SLIGHT CORROSION WAS OBSERVED. THE OBSERVED CORROSION WAS LIKELY INCIDENTAL AND UNRELATED TO THE REPORTED EVENTS. EVALUATION OF THE TUBING REVEALED THAT THE RETURNED PORTION WAS FUNCTIONAL. THE TUBING WAS FLUSHED WITH FLUID AND AIR DURING DECONTAMINATION WITHOUT AN ISSUE. SINCE ONLY A PORTION OF THE TUBING WAS RETURNED FOR EVALUATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED. PENUMBRA PUMPS ARE VISUALLY AND FUNCTIONALLY INSPECTED DURING INCOMING QUALITY INSPECTION. PENUMBRA TUBING IS VISUALLY INSPECTED DURING IN-PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2016-01604.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX) AND THE INDIGO SYSTEM ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE PUMP MAX WAS POWERED ON AND THE GREEN POWER BUTTON ILLUMINATED BUT THE PUMP MAX WAS UNABLE TO CREATE VACUUM. IN ADDITION, THE PHYSICIAN NOTICED THAT THE VALVE ON THE TUBING WOULD NOT OPEN. THE TECHNICIAN THEN CHANGED OUT THE TUBING FOR A NEW PENUMBRA SYSTEM ASPIRATION TUBING (NEW TUBING) AND UNPLUGGED THE PUMP MAX SEVERAL TIMES. AFTER ABOUT THREE MINUTES OR SO, THE PUMP MAX WAS ABLE TO PRODUCE VACUUM THROUGH THE NEW TUBING. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX AND THE NEW TUBING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746888 INDIGO SYSTEM ASPIRATION TUBING DXE DXE PENUMBRA, INC. F69092 00814548016221

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR