MEDITECH CRITICAL CARE FLOWSHEETS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-09 for MEDITECH CRITICAL CARE FLOWSHEETS manufactured by Medical Information Technology.

Event Text Entries

[47294435] We have some protocols for critical care drips that involve fractions, e. G. , (if xyz holds drip for 30 minutes and resume at x/x previous rate). We use (b)(6) as our hospital emr. (b)(4), which we write our protocols and policies in, will autoconvert x/x (among others) into the proper fraction font. When we cut and paste that protocol into an order set build, (b)(4) will show that fraction font. However, when the order set protocol is viewed by the nurse on the emar, the fraction font is simply omitted, resulting in a medication error. (b)(4) has worked with us on this, and determined that various pieces of their system may or may not show those fraction fonts (or any ascii extended character) and their guidance is to instruct users to simply never copy and paste, as it may be a long involved rebuild of many pieces of their software to prevent this bug from occurring. While we see that (b)(4) says to use these fraction fonts, they also say to follow it by (fraction-in-words) as a safety measure, which we are now implementing. However, the issue still remains, some places in the system show different text than other places in the system because of the inconsistent way ascii extended characters are handled in (b)(4). Medication not administered to or used by the patient: no. Relevant materials not provided: none, severity: circumstances or events have capacity to cause error. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5062777
MDR Report Key5719898
Date Received2016-06-09
Date of Report2016-04-08
Date Added to Maude2016-06-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMEDITECH CRITICAL CARE FLOWSHEETS
Generic NameMEDITECH CRITICAL CARE FLOWSHEETS
Product CodeNSX
Date Received2016-06-09
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDICAL INFORMATION TECHNOLOGY


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-09

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