BEUDAMED
    FDA Adverse Event Other Summary report: N

    EHR SYSTEM

    MDR report key: 4189165 · Received October 15, 2014

    Report

    Report Number
    MW5038641
    Event Type
    Other
    Date Received
    October 15, 2014
    Product Code
    NSX
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOES RANGE CHECKING IN THE EHR SYSTEM DOES NOT FOLLOW CLINICAL LOGIC. WHEN ENTERING AN IV ORDER UTILIZING MULTIPLE VIALS OF THE SAME MEDICATION TO ACCOMMODATE DOSING AND MINIMIZE WASTE SUCH IS COMMON PRACTICE IN ONCOLOGY PHARMACY, THE DOSE RANGE CHECKING SYSTEM DOES NOT FUNCTION WITH THE LOGIC A CLINICIAN WOULD EXPECT. FOR EXAMPLE, WHEN AN ORDER IS ENTERED (OR VERIFIED BY THE PHARMACIST) THAT WOULD CONTAIN TWO DIFFERENT VIALS SIZES, THE SYSTEM DOES NOT CHECK THE DOSE BASED ON THE TOTAL DOSE TO BE ADMINISTERED. RATHER, THE SYSTEM LOOKS TO EACH INDIVIDUAL VIAL. THIS COULD LEAD TO AN OVER DOSE IF THE INDIVIDUAL VIA SIZES WHERE WITHIN THE DOSING LIMIT BUT THE COMBINED VIAL SIZES OR ACTUAL DOSES WAS ABOVE THE DOSING LIMIT. THIS ERROR COULD OCCUR WITH COMMONLY USED ONCOLOGY MEDICATIONS SUCH AS BEVACIZUMAB (AVASTIN) GEMCITABINE (GEMZAR) IXABEPILONE (IXEMPRA) BENDAMUSTINE (TREANDA) TEST YOUR SYSTEM UNDER ALL CIRCUMSTANCES TO MAKE SURE YOU UNDERSTAND HOW IT FUNCTIONS AND MORE IMPORTANTLY WHAT ARE IT'S LIMITATIONS. SUBMIT ENHANCEMENTS TO VENDORS TO MAKE THEM AWARE OF THE POTENTIAL FOR ERROR. REPORTER'S RECOMMENDATIONS: TEST YOUR SYSTEM UNDER ALL CIRCUMSTANCES TO MAKE SURE YOU UNDERSTAND HOW IT FUNCTIONS AND MORE IMPORTANTLY WHAT ARE IT'S LIMITATIONS. SUBMIT ENHANCEMENTS TO THE VENDORS TO MAKE THEM AWARE OF THE POTENTIAL FOR ERROR. RELEVANT MATERIALS PROVIDED: NONE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652422 EHR SYSTEM NONE NSX

    Patients

    Seq Age Sex Outcome Treatment
    1 GEMCITABINE(GEZAR)| IXABEPILONE(IXEMPRA)| BENDAMUSTINE (TRENDA)| BEVACIZUMAB(AVASTIN)