BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL INTRAVENOUS FILTER FOR TOTAL NUTRIENT ADMIXTURES CONTAI

    MDR report key: 139131 · Received December 22, 1997

    Report

    Report Number
    2432733-1997-00062
    Event Type
    Death
    Date Received
    December 22, 1997
    Date of Event
    May 12, 1997
    Report Date
    July 9, 1997
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    FPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE HRS FROM THE START OF AN INFUSION OF TOTAL NUTRIENT ADMIXTURE THROUGH THE DEVICE IT WAS NOTICED THAT THE INLET HOUSING WAS LEAKING. THE DEVICE WAS CHANGED AND THREE HRS LATER A LEAK WAS NOTICED AGAIN ON THE INLET HOUSING. THE PT WAS DISCHARGED AFTER TREATMENT. THE FOLLOWING DAY THE PT WAS RE-ADMITTED WITH PYREXIA. THIS WAS DETERMINED TO ORIGINATE FROM SEPTICEMIA, AND LATER THE PT DIED. THE USER FACILITY INQUIRED WHETHER THE SEPTICEMIA AND CATHETER TIP CONTAMINATION COULD BE RELATED TO THE LEAK AT THE DEVICE INLET PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL INTRAVENOUS FILTER FOR TOTAL NUTRIENT ADMIXTURES CONTAI INTRAVENOUS FILTER FOR TOTAL NUTRIENT ADMIXTURES CONTAINING FPB PALL BIOMEDICAL PRODUCTS CO. TNA1 620101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death