BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRATION PUMP CANISTER

    MDR report key: 1963757 · Received December 22, 2010

    Report

    Report Number
    3005168196-2010-00714
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DID NOT RETURN FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. DATA TRENDING AND ANALYSIS REVIEWED BY PENUMBRA'S COMPLAINT COMMITTEE INDICATED THERE WAS A TREND ASSOCIATED WITH CRACKED CANISTERS. WE INVESTIGATED AND DETERMINED THAT ALTHOUGH CRACKED CANISTERS ARE STILL CAPABLE OF HOLDING PRESSURE, THE OCCURRENCE OF THIS FAILURE WAS DEEMED TOO HIGH AND RESULTED IN USER DISSATISFACTION. AS A RESULT, PENUMBRA OPENED A CAPA AND IMPLEMENTED ACTIONS WHICH INCLUDED (B)(4). THIS CAPA IS CURRENTLY BEING EVALUATED FOR EFFECTIVENESS. THE FAILURE RATE FOLLOWING THE IMPLEMENTATION OF THE NEW SHIPPING CONTAINER/CONFIGURATION IS CURRENTLY AT 0.11% AS COMPARED TO 0.35% PRIOR TO IMPLEMENTATION OF THE NEW SHIPPER. THE CANISTER IN THIS CASE WAS ASSEMBLED IN THE OLD SHIPPING CONFIGURATION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A CRACK IN THE BOTTOM OF A CANISTER "RUNNING UP ABOUT 1/4 OF ONE SIDE." THE CRACKED CANISTER WAS DISCARDED ONCE THE CRACK WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRATION PUMP CANISTER POWERED SUCTION PUMP JCX PENUMBRA, INC. B00028

    Patients

    Seq Age Sex Outcome Treatment
    1