BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRIUM

    MDR report key: 672164 · Received February 2, 2006

    Report

    Report Number
    1219977-2006-00001
    Event Type
    Other
    Date Received
    February 2, 2006
    Date of Event
    October 31, 2005
    Report Date
    January 13, 2006
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD CHEST TUBE CONNECTED TO ATRIUM H2O SEAL. REN NOTED ON ROUNDS THE PT HAD AN INCREASE IN SUBCUTANEOUS EMPHYSEMA OVER CHEST AND ABDOMEN. WATER SEAL WAS DRY. PHYSICIAN NOTIFIED AND CHEST TUBE PLACED BACK ON SUCTION. THE NEXT DAY THE PT WAS PUT BACK ON ATRIUM WITH WATER SEAL. INVESTIGATION REVEALED THE NURSE HAD CHANGED THE ATRIUM DRAINAGE SYSTEM THE DAY BEFORE, BECAUSE THE CHAMBERS WERE FULL AND FORGOT TO ADD THE WATER TO THE AIRLEAK CHAMBER. THE OMISSION WAS NOT PICKED UP, UNTIL THE NEXT DAY. THE PT DID NOT HAVE LASTING INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM CHEST DRAINAGE SYSTEM KDQ ATRIUM MEDICAL CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization