ELECTRONIC MEDICATION ADMINISTRATION RECORD (EMAR)

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 ELECTRONIC MEDICATION ADMINISTRATION RECORD (EMAR) manufactured by .

Event Text Entries

[5093493] Delay in administration of a pre-operative antibiotic due to disparate information within the ehr. A physician entered an order for cefazolin 2 gram to be administered pre-operatively. The pharmacist correctly adjusted the administration time to coincide with facility standards. Unfortunately, the ehr displays the order status differently in the operating room system (where operating room nurses record drug administration) verses the electronic medication administration record (emar). In certain instances, the system will show the status of a "one time" order as discontinued 1 minute after it was placed. The emar will maintain a status of active until it is administered when it will immediately show as discontinued. Conversely, the operating room system follows the system convention and displays the medication as discontinued 1 minute after it is ordered, even though it has not been administered. The operating room nurse, have seen the cerfazolin order with a status of "discontinued", did not administer the cefazolin which led to a delay in care. Vendors should be expected to display order status consistently across their software modules. The ehr used in this case is considered a fully integrated ehr platform yet it does not function in that fashion. Where did the error occur: hospital. Hospital unit: operating room. Type of staff made initial error: nurse. Pt counseling provided: unk. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038642
MDR Report Key4189145
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 NameELECTRONIC MEDICATION ADMINISTRATION RECORD (EMAR)
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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