BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOCARE

    MDR report key: 1871361 · Received October 12, 2010

    Report

    Report Number
    3006153342-2010-00001
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    April 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    HEALTH ROBOTICS S.R.L.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PTS REC'D UNDERDOSE CONCENTRATIONS OF CYTOTOXIC COMPOUNDS WHICH WERE COMPOUNDED BY CYTOCARE (THE MEDICAL DEVICE). THE DEVICE PREPARED THE WRONG DOSE OF MEDICATIONS AS A CONSEQUENCE OF INTERFACE SOFTWARE CHANGE UNDER IMPLEMENTATION AT THE HOSPITAL PHARMACY. ON SITE CHANGES WERE REQUIRED BECAUSE OF THE UNFEASIBILITY OF PRE-TESTING AND VALIDATION: THE OTHER PARTY INFORMATION SYSTEM INVOLVED (PHARMACY INFORMATION SYSTEMS, SELF-DEVELOPED BY THE USER FACILITY) IS IN FACT AVAILABLE AT THE INSTALLATION SITE ONLY. AN ON-SITE TEST AND VALIDATION PHASE WAS THEREFORE PLANNED AND AGREED TO ENSURE THE REQUIRED CHANGES WOULD NOT AFFECT THE PROPER FUNCTIONING OF THE DEVICE AND THE PHARMACY'S PRESCRIPTION SYSTEM. LIKELY, A MISCOMMUNICATION AMONG HOSPITAL, MANUFACTURER AND AUTHORIZED SERVICE ENTITY DID NOT PROPERLY TRANSFER THE INFORMATION TO THE PHARMACY PERSONNEL THAT THE DEVICE SHOULD NOT TO BE USED UNTIL THE END OF THE INSTALLATION AND SUCCESSFUL VALIDATION OF THE CHANGES. NO PT INJURY OR ANY OTHER RELEVANT MEDICAL CONSEQUENCES WERE REPORTED. THE INTERFACE SOFTWARE PROBLEM WAS IDENTIFIED AND CORRECTED THE SAME DAY OF THE EVENTS BY RESTORING THE PREVIOUS VALIDATED INTERFACE SOFTWARE VERSION. NO OTHER DEVICES ARE INVOLVED, SINCE IT WAS A UNIQUE SITUATION RELATED TO THE HOSPITAL'S SELF-DEVELOPED PRESCRIPTION SYSTEM AND ITS CUSTOMIZED DATA EXCHANGE TO THE DEVICE.

    Description of Event or Problem · 1

    AS PER (B)(4), THE HOSPITAL REPORTED: "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 THE 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." TWO PTS WERE INVOLVED.

    Additional Manufacturer Narrative · 2

    TWO PTS REC'D UNDERDOSE CONCENTRATIONS OF CYTOTOXIC COMPOUNDS WHICH WERE COMPOUNDED BY CYTOCARE (THE MEDICAL DEVICE). THE DEVICE PREPARED THE WRONG DOSE OF MEDICATIONS AS A CONSEQUENCE OF INTERFACE SOFTWARE CHANGE UNDER IMPLEMENTATION AT THE HOSPITAL PHARMACY. ON SITE CHANGES WERE REQUIRED BECAUSE OF THE UNFEASIBILITY OF PRE-TESTING AND VALIDATION: THE OTHER PARTY INFORMATION SYSTEM INVOLVED (PHARMACY INFORMATION SYSTEMS, SELF-DEVELOPED BY THE USER FACILITY) IS IN FACT AVAILABLE AT THE INSTALLATION SITE ONLY. AN ON-SITE TEST AND VALIDATION PHASE WAS THEREFORE PLANNED AND AGREED TO ENSURE THE REQUIRED CHANGES WOULD NOT AFFECT THE PROPER FUNCTIONING OF THE DEVICE AND THE PHARMACY'S PRESCRIPTION SYSTEM. LIKELY, A MISCOMMUNICATION AMONG HOSPITAL, MANUFACTURER AND AUTHORIZED SERVICE ENTITY DID NOT PROPERLY TRANSFER THE INFORMATION TO THE PHARMACY PERSONNEL THAT THE DEVICE SHOULD NOT TO BE USED UNTIL THE END OF THE INSTALLATION AND SUCCESSFUL VALIDATION OF THE CHANGES. NO PT INJURY OR ANY OTHER RELEVANT MEDICAL CONSEQUENCES WERE REPORTED. THE INTERFACE SOFTWARE PROBLEM WAS IDENTIFIED AND CORRECTED THE SAME DAY OF THE EVENTS BY RESTORING THE PREVIOUS VALIDATED INTERFACE SOFTWARE VERSION. NO OTHER DEVICES ARE INVOLVED, SINCE IT WAS A UNIQUE SITUATION RELATED TO THE HOSPITAL'S SELF-DEVELOPED PRESCRIPTION SYSTEM AND ITS CUSTOMIZED DATA EXCHANGE TO THE DEVICE.

    Description of Event or Problem · 2

    AS PER (B)(4), THE HOSPITAL REPORTED: "AUTOMATED CHEMOTHERAPY DISPENSING MACHINE UNDERDOSED TWO DOSES. SUBSEQUENT INVESTIGATION REVEALED AN UNAUTHORIZED SOFTWARE CHANGE BY VENDOR WAS MADE DURING OF SOFTWARE UPDATE THAT WAS PLANNED AND TESTED (BOTH BY VENDOR AND ON-SITE). THIS CAUSED THE MACHINE TO INCORRECTLY CALCULATED DOSES. THE MACHINE DOUBLE DIVIDED THE DOSE OF THE MEDICATION BY THE CONCENTRATION OF THE STOCK THE 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." TWO PTS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTOCARE CYTOCARE NEP HEALTH ROBOTICS S.R.L. CYTOCARE REVISION B

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other
    2 UNK