BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V

    MDR report key: 6881406 · Received September 20, 2017

    Report

    Report Number
    3005168196-2017-01632
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 29, 2017
    Report Date
    August 29, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    UDI-DI
    00814548012773
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX) HAD BLOOD ON ITS OUTER HOUSING NEAR THE SUCTION INLET AND INSIDE THE DEVICE. CONCLUSION: EVALUATION OF THE RETURNED PUMP MAX CONFIRMED BLOOD ON AND INSIDE THE PUMP HOUSING. THIS IS A RESULT OF INCORRECTLY HOOKING THE ASPIRATION TUBING DIRECTLY TO THE PUMP MAX SUCTION INLET RATHER THAN THE PUMP MAX CANISTER. IF BLOOD IS ASPIRATED DIRECTLY INTO THE PUMP MAX, IT MAY PREVENT THE DEVICE FROM FUNCTIONING. PENUMBRA PUMPS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. 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 USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION TUBING WAS INCORRECTLY CONNECTED TO THE PUMP MAX SUCTION INLET INSTEAD OF THE PUMP MAX CANISTER; THEREFORE, UPON ASPIRATION, BLOOD ENTERED THE PUMP MAX. THE HOSPITAL STAFF TURNED OFF THE PUMP MAX AS SOON AS THEY REALIZED THAT THE PUMP MAX WAS MIS-CONNECTED AND PUT A CANISTER IN PLACE. ALTHOUGH BLOOD ENTERED THE PUMP MAX, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE USING THE SAME PUMP MAX. IT WAS REPORTED THAT THE PUMP MAX WOULD NOT TURN ON THE NEXT DAY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660218 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX JCX PENUMBRA, INC. F08059-32 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR