BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINER 1000CC FLEX ADUENT

    MDR report key: 1371238 · Received April 27, 2009

    Report

    Report Number
    1423507-2009-00049
    Event Type
    Death
    Date Received
    April 27, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 28, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE FLEX 1000CC LID/LINER ASSEMBLY SAMPLE WAS RETURNED FROM THE CUSTOMER SITE IN 2009. THE UNIT DID NOT APPEAR TO HAVE BEEN USED. DURING THE INVESTIGATION, THE LID DATE CODE WAS DETERMINED TO BE THE MONTH BEFORE, WHICH IS INDICATIVE OF THE LID MOLDING DATE. THEREFORE, THIS UNIT WOULD NOT BE PART OF THE LOT REPORTED, J902-359, WHICH WAS PACKED OUT FEB 12, 2009. THE RETURNED SAMPLE MET ALL VISUAL AND FUNCTIONAL REQUIREMENTS. PREMATURE SHUT OFF CONDITIONS WERE DUPLICATED AND VACUUM RESTORED PER OUR DIRECTIONS FOR USE. AS THE ACTUAL PRODUCT INVOLVED WAS NOT RETURNED FOR EVALUATION, WE ARE UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE OF THE PROBLEM DESCRIBED.

    Description of Event or Problem · 1

    DURING A CODE, THE SUCTION APPARATUS (WALL SUCTION) WAS ACTIVATED TO SUCTION THE PT'S MOUTH PRIOR TO INTUBATION. NURSING STAFF STATE THAT UPON TURNING THE SUCTION ON IT WAS WORKING PROPERLY, HOWEVER, AS THEY ATTEMPTED TO SUCTION SECRETIONS FROM THE PT'S MOUTH, IT ABRUPTLY STOPPED WORKING. THEY STATE THAT THEY NEEDED TO DISCONTINUE USING THIS SUCTION AND USE AN ALTERNATIVE SOURCE TO ACCOMPLISH THE TASK OF SUCTIONING THE PT'S SECRETIONS. PER THE HOSP, THEY " SWITCHED THE CATH TO ANOTHER CANISTER AT THE 2ND BED AND IT WORKED FINE." SHE'S NOT SURE HOW LONG THE DELAY WAS, WHETHER IT WAS SECONDS OR MINUTES. THE PT EVENTUALLY EXPIRED. HOSPITAL REPORTED THAT THE PT "HAD A LOT OF MEDICAL PROBLEMS" BUT PROVIDED NO DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINER 1000CC FLEX ADUENT SUCTION LINER KDQ CARDINAL HEALTH 65651-910C J902-359

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death