BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IS PAC INTER SORB PLUS C02 ABSORBENT CANISTER

    MDR report key: 1775742 · Received July 22, 2010

    Report

    Report Number
    1319447-2010-00001
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 23, 2010
    Manufacturer
    INTERSURGICAL, INC.
    Product Code
    CBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A PRODUCT TRIAL TWO OF THE CANISTERS APPEARED TO DEVELOP A LEAK 60 TO 90 MINUTES INTO THE SURGICAL PROCEDURE. THE TWO CANISTERS PASSED THE INITIAL PRESSURE TEST. SIX ADDITIONAL CANNISTERS FAILED THE INITIAL PRESSURE TEST. TWO ADD'L CANISTERS WERE FOUND TO BE CRACKED WHEN REMOVED FROM THEIR SHIPPING CASE AND NOT TESTED FOR USE. ALL TEN CANNISTERS WERE DISCARDED. WHEN THE FIRST CANISTER LEAKED DURING USE, THE SURGICAL PROCEDURE WAS STOPPED AND THE PATIENT WAS BAGGED UNTIL THE CANISTER WAS REPLACED. NO INTERVENTION WAS REQUIRED WHEN THE SECOND CANISTER LEAKED WAS A REPLACEMENT CANISTER WAS ON HAND IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IS PAC INTER SORB PLUS C02 ABSORBENT CANISTER ABSORBENT CANISTER CBL INTERSURGICAL, INC. 2216 1101511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention