BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM MAX ASPIRATION TUBING

    MDR report key: 4700719 · Received April 16, 2015

    Report

    Report Number
    3005168196-2015-00377
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 17, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2015-00378 AND 00379. THE HOSPITAL DISCARDED THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM MAX ASPIRATION TUBING, PENUMBRA SYSTEM NON-STERILE PUMP MAX SUPPLIES CANISTER, AND PENUMBRA SYSTEM ASPIRATION PUMP MAX 110. THE PHYSICIAN ATTEMPTED TO ASPIRATE BY TURNING ON THE PUMP MAX, HOWEVER, IT WOULD NOT ASPIRATE. THE GAUGE SHOWED THE PUMP MAX CREATED A VACUUM OF -29 INHG. THE PHYSICIAN HELD THEIR FINGER OVER THE OPENING IN THE PUMP MAX SUPPLIES CANISTER AND FOUND THAT NO VACUUM WAS BEING GENERATED. THE PROCEDURE SUCCESSFULLY CONTINUED USING NEW PENUMBRA SYSTEM MAX ASPIRATION TUBING, PENUMBRA SYSTEM NON-STERILE PUMP MAX SUPPLIES CANISTER, AND PENUMBRA SYSTEM ASPIRATION PUMP MAX 110. AFTER THE PROCEDURE, THE CANISTER IN THE PUMP MAX SUPPLIES CANISTER SUPPLIES WAS DISASSEMBLED AND REASSEMBLED AND THE PUMP MAX PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255585 PENUMBRA SYSTEM MAX ASPIRATION TUBING JCX JCX PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1