BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT,LAP CHOLE (CGWG )186

    MDR report key: 3023998 · Received March 27, 2013

    Report

    Report Number
    1423537-2013-00013
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NINE (9) UNUSED SAMPLES WERE RETURNED FROM THE CUSTOMER. VISUAL INSPECTION OF THESE SAMPLES CONFIRMED THAT THE BREATHING FILTER AND BREATHING CIRCUIT WERE IN THEIR ORIGINAL PACKAGING. AFTER INTERVIEWING THE MANUFACTURING PERSONNEL AND CONDUCTING A REVIEW OF THE SYSTEMS, THE ROOT CAUSE HAS BEEN IDENTIFIED AS OPERATOR ERROR. BASED ON THE ASSIGNED ROOT CAUSE, CORRECTIVE ACTIONS HAVE BEEN INITIATED. THE OPERATORS HAVE BEEN TRAINED ON THE NEW INSTRUCTIONS AND VISUAL JOB AIDS HAVE BEEN CREATED AND DISTRIBUTED TO REINFORCE THE NEW INSTRUCTIONS. MANUFACTURING INSTRUCTIONS HAVE BEEN REVIEWED AND UPDATED IN ORDER TO PROVIDE GREATER CLARITY WHEN REMOVING PACKAGING PRIOR TO CONNECTING THE COMPONENTS. IN ADDITION TO THESE ACTIONS A VOLUNTARY RECALL HAS BEEN INITIATED BY CARDINAL HEALTH.

    Description of Event or Problem · 1

    PER CUSTOMER, UPON OPENING THE LAP CHOLE KIT, CATALOG NUMBER: PG24LCGWG COMPONENTS 002862 BREATHING FILTER AND 650904 BREATHING ANESTHESIA CIRCUIT WERE FOUND TO BE ATTACHED WITH THE BREATHING FILTER AND BREATHING CIRCUIT IN THEIR ORIGINAL PACKAGING. WHEN THE SETUP UP WAS PUT INTO USE, THE PATIENT'S OXYGEN SATURATION FELL. THE SITUATION WAS CORRECTED DURING THE PROCEDURE, WITH THE PATIENT BEING DISCONNECTED FROM THE CIRCUIT AND THEN RE-INTUBATED. THE SURGERY WAS COMPLETED AND THE PATIENT SUFFERED NO ILL EFFECTS OR COMPLICATIONS FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126718 KIT,LAP CHOLE (CGWG )186 KIT,LAP CHOLE LRO CARDINAL HEALTH PG24LCGWG NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention