BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOCARE

    MDR report key: 1662909 · Received April 14, 2010

    Report

    Report Number
    1662909
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 14, 2010
    Manufacturer
    HEALTH ROBOTICS S.R.L.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AUTOMATED CHEMOTHERAPY DISPENSING MACHINE UNDERDOSED TWO DOSES. SUBSEQUENT INVESTIGATION REVEALED AN UNAUTHORIZED SOFTWARE CHANGE BY VENDOR WAS MADE DURING A SOFTWARE UPDATE THAT WAS PLANNED AND TESTED (BOTH BY VENDOR AND ON-SITE). THIS CAUSED THE MACHINE TO INCORRECTLY CALCULATE DOSES. THE MACHINE DOUBLE DIVIDED THE DOSE OF THE MEDICATION BY THE CONCENTRATION OF THE STOCK MEDICATION SOLUTION. FOR EXAMPLE, IF THE DOSE WAS 72MG, THE STOCK MED WAS 6MG/ML, THE MACHINE SHOULD ADD 12ML TO THE IV BAG. IN THIS CASE, THE MACHINE DIVIDED 72 BY 6 AND THEN BY 6 AGAIN SO ONLY 2ML WERE ADDED TO THE BAG.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNDERDOSED THE MEDICATION====================== MANUFACTURER RESPONSE FOR IV MEDICATION COMPOUNDER, CYTOCARE CHEMOTHERAPY COMPOUNDER======================THEY HAVE PERFORMED SOFTWARE UPDATES AND ON-SITE VALIDATION OF MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTOCARE IV MEDICATION COMPOUNDER, CHEMOTHERAPY COMPOUNDER NEP HEALTH ROBOTICS S.R.L. * 03042032-01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR CHEMOTHERAPY