BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA NON-STERILE PUMP MAX CANISTER

    MDR report key: 3253008 · Received July 29, 2013

    Report

    Report Number
    3005168196-2013-00297
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 30, 2013
    Report Date
    June 30, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CANISTER LOOKS TO BE IN GOOD CONDITION, BUT THE CONNECTOR FROM THE FILTER TO THE PUMP IS MISSING. THE CANISTER IS NONFUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT STATES THAT THE CONNECTOR FROM THE FILTER TO THE PUMP WAS MISSING. DURING THE EVALUATION OF THE PRODUCT THE CONNECTOR FOR THE FILTER TO PUMP WAS NOT PRESENT. HOWEVER, RAW MATERIAL RECONCILIATION FOR THE ASPIRATION PUMP FILTER REVEALED THAT THE NUMBER OF ASPIRATION PUMP FILTERS PULLED FROM INVENTORY WAS EQUAL TO THE NUMBER OF PUMP CANISTERS RELEASED IN THIS LOT. THEREFORE, THE CAUSE OF THIS COMPLAINT CANNOT BE DIRECTLY DETERMINED. 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

    UPON SETTING UP A NEW MAX CANISTER FOR THE PENUMBRA MAX PUMP, IT WAS DISCOVERED THAT THE WHITE CONNECTION ATTACHED TO THE FILTER, WHICH CONNECTS THE PUMP TO THE FILTER, WAS MISSING. A SECOND CANISTER WAS REMOVED FROM INVENTORY AND NO ISSUES WERE ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352762 PENUMBRA NON-STERILE PUMP MAX CANISTER JCX JCX PENUMBRA, INC. B000209

    Patients

    Seq Age Sex Outcome Treatment
    1