EHR SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-15 for EHR SYSTEM manufactured by .

Event Text Entries

[5093050] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038641
MDR Report Key4189165
Date Received2014-10-15
Date Added to Maude2014-10-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEHR SYSTEM
Generic NameNONE
Product CodeNSX
Date Received2014-10-15
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-15

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