BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC HI VOLUME HOG FOR TPN ADMIN

    MDR report key: 204805 · Received December 29, 1998

    Report

    Report Number
    204805
    Event Type
    Malfunction
    Date Received
    December 29, 1998
    Date of Event
    November 22, 1998
    Report Date
    November 30, 1998
    Manufacturer
    SIMS DELTEC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER PT TELEPHONE REPORT, SHE GOT UP TO KITCHEN FOR SNACK IN EARLY AM HOURS (0500) TURNED AROUND AND NOTED BLOOD ON FLOOR. PT NOTED THAT TUBING WAS CLEARLY BROKEN OFF BELOW 0.2 UG FILTER. SHE IMMEDIATELY DISCONNECTED INTRAVENOUS LINE AND FLUSHED HICKMAN WITH 30 ML SALINE THEN HEPARIN CATH FLUSHED EASILY. AT SUBSEQUENT PLANNED "SNV" HOG RETRIEVED FROM PT HICKMAN FLUSHES WITH EASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTEC HI VOLUME HOG FOR TPN ADMIN 0.2 UG FILTER FPA SIMS DELTEC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other