BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110

    MDR report key: 4896948 · Received July 7, 2015

    Report

    Report Number
    3005168196-2015-00657
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    May 23, 2015
    Report Date
    June 7, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. PUMP WAS FOUND TO BE FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: F07421-23. (B)(6). MANUFACTURE DATE: 3/4/2014. 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 110. DURING PREPARATION FOR THE PROCEDURE, THE NURSE CONNECTED THE PENUMBRA SYSTEM MAX ASPIRATION TUBING DIRECTLY TO THE PUMP MAX; RATHER THAN CONNECTING TO THE PENUMBRA SYSTEM PUMP MAX NON-STERILE SUPPLIES CANISTER. AFTER SUCCESSFULLY ASPIRATING SOME THROMBUS, THE PHYSICIAN NOTICED THE ERROR AND SWITCHED THE CONNECTION AND THE PROCEDURE SUCCESSFULLY CONTINUED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440767 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 JCX JCX PENUMBRA, INC. F07421-23

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR