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 Number: MW5043991
• MDR Report Key: 4908705
• Date Received: 2015-07-06
• Date Added to Maude: 2015-07-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: CPE ORDER SYSTEM
• Product Code: NSX
• Date Received: 2015-07-06
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-07-06