CPE ORDER SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for CPE ORDER SYSTEM manufactured by Unk.

Event Text Entries

[19983718] Just wanted to share a story concerning the removal of medications from formulary can cause down stream problems. The manufacturers that make normal saline 150 ml bags discontinued the product. In our cpoe order system we had acyclovir pre-programmed with an iv set of the drug in 150 ml bags. When these bags were discontinued the system was updated with acyclovir to be mixed in 100 ml bags. The problem was we had built an alert in our smart pumps if the concentration exceeded 7 mg/ml (increased risk of phlebitis). Since the dosing of acyclovir is based on ibw we would never exceed this concentration when it was built with the 150 ml bag. However, we had alerts fire now that the bag is built with the 100 ml total volume. A nurse overrode the alert (soft alert). No harm was done however, this goes to show you must do an evaluation of your system whenever something is removed from your formulary as well because it can have down stream effects. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5043991
MDR Report Key4908705
Date Received2015-07-06
Date Added to Maude2015-07-14
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 FDA0
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameCPE ORDER SYSTEM
Product CodeNSX
Date Received2015-07-06
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-06

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