BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV PRM 1LWR CLV 100"

    MDR report key: 477841 · Received August 7, 2003

    Report

    Report Number
    9613251-2003-00121
    Event Type
    Malfunction
    Date Received
    August 7, 2003
    Date of Event
    July 10, 2003
    Report Date
    July 14, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "CLIENT REPORTS THAT THE IV SPIKE FELL OUT OF AN ABBOTT IV SOLUTION BAG CONTAINING CHEMOTHERAPY. THE SPILL CAUSED STAFF AND PATIENT ANTI-NEOPLASTIC EXPOSURE BY AEROSOL AND STAFF EXPOSURE ON SKIN. AS WELL, THERE WAS A SPILL IN THE ROOM. HOSPITAL PROTOCOL WAS FOLLOWED FOR BOTH ROOM CLEAN UP AS WELL AS PATIENT AND STAFF EXPOSURE. ETOPISIDE IS ADDED TO ABBOTT'S 0.9% NORMAL SALINE ONE LITER BAG, LIST# 7983-154 LOT UNIDENTIFIED, VIA THE ADMINISTRATION PORT BY PHARMACY. THE IV BAG SPIKE ACCESS IS UNTOUCHED. THE IV BAG IS THEN SPIKED AND THE TUBING IS BACK PRIMED WITH 0.9% NORMAL SALINE FROM THE PRIMARY IV LINE. THE TUBING WAS NOT RESPIKING THE BAG. THE DISCONNECT OCCURRED AS THE CLINICIAN WAS IN THE PROCESS OF HANGING THE ETOPISIDE IV BAG ON THE IV POLE. THE INFUSION WAS TO RUN BY GRAVITIY. THE ENTIRE SET-UP WAS DISCARDED AND A NEW DRUG AND SET-UP WAS INSTALLED WITH NO FURTHER INCIDENTS." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV PRM 1LWR CLV 100" ADMINISTRATION SET FPA ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other ABBOTT 0.9% SODIUM CHLORIDE INJECTION, LIST #07983| LOT# UNK, ETOPISIDE (MFR UNK).