BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGEN TUBING

    MDR report key: 996554 · Received February 8, 2008

    Report

    Report Number
    2921601-2008-00001
    Event Type
    Death
    Date Received
    February 8, 2008
    Date of Event
    October 19, 2007
    Report Date
    February 6, 2008
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED, WE CONCLUDE THAT IT WAS USER/PATIENT ERROR. THERE IS NO EVIDENCE THAT THE OXYGEN TUBING INVOLVED IN THE INCIDENT, OR ANY OTHER SIMILAR TUBING IN DISTRIBUTION IS DEFECTIVE. OUR INVESTIGATION IS COMPLETE WITH NO CORRECTIVE ACTION REQUIRED. THIS INCIDENT WAS ALSO REPORTED TO THE MEDICAL DEVICES VIGILANCE SYSTEM BFARM - CASE.

    Description of Event or Problem · 1

    THE PT WHILE IN A HOSP IN ANOTHER COUNTRY, GOT RID OF THE INFUSION DEVICE TO GO TO THE TOILET. AFTERWARDS HE CONNECTED TUBE WITH THE 3-WAY PLUG OF THE INFUSION. THEREBY IT CAME TO AN AIR EMBOLISM WHICH LED TO THE DEATH OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN TUBING OXYGEN TUBING CAT SALTER LABS 13400 030507

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death