BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLASTIC BAG AND TUBING FOR TPN

    MDR report key: 11796 · Received March 1, 1994

    Report

    Report Number
    MW1000915
    Event Type
    Death
    Date Received
    March 1, 1994
    Date of Event
    January 1, 1994
    Report Date
    March 1, 1994
    Manufacturer
    MCGAW, INC.
    Product Code
    KPE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO PTS WERE GIVEN TPN USING THIS PLASTIC BAG AND TUBING. BOTH PTS EXPIRED. AUTOPSY SHOWED THAT BOTH PTS HAD MICROCALCIFICATION IN THE LUNGS. THE LUNG TISSUE CONTAINED CALCIUM BUT IT WAS NOT A TYPICAL PRECIPITATE. THE 31-YR-OLD PT UNDERWENT AN EXPLORATORY LAPAROTOMY FOR ADHESIONS. THE 37-YR-OLD PT HAD SURGERY TO REMOVE AND APPENDICEAL ABSCESS. IT IS SUSPECTED THAT 14 OTHER PTS MAY HAVE BEEN AFFECTED, INCLUDING AN ELDERLY PT WHO EXPIRED BUT ON WHOM NO AUTOPSY WAS PERFORMED. THE REPORTER STATED THAT SHE WAS TOLD THAT WHEN ANOTHER CO'S BAG AND TUBING WERE USED TO ADMINISTER TPN, THERE WERE NO PROBLEMS. THE REPORTER ALSO WAS TOLD THAT THIS CO STATED THAT THERE WAS A COATING IN THE BAG. IN RETROSPECT, THE PERSONNEL INVOLVED IN THESE INCIDENTS REPORTED THE PRESENCE OF A PRECIPITATE IN THE TUBING. THE REPORTER BECAME AWARE OF THE INCIDENTS THROUGH SLIDES SENT TO PATHOLOGY. THE REPORTER STATED THAT SHE WAS AWARE THAT ONE OF THE INGREDIENTS GIVEN TO THE PTS WAS 10% FREAMINE; SHE STATED THAT THE TPN SOLUTION WAS NOT SUSPECTED AS CAUSING THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASTIC BAG AND TUBING FOR TPN KPE MCGAW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death