Logix Order Entry (OE) Software 의 리콜

Recall

59734

Class 2

Z-3276-2011

2011-08-15

2011-09-23

Terminated

United States

2017-01-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103498

There is the potential for an order entry error during use of the logix order entry (oe) software. when adding ingredients to a tpn order, the user can accept the pre-populated "per units" of "bag" or select other "per units". a dosing error may occur if the user does not select the prescribed "per units" for the added ingredient.

Baxter Healthcare Corp. sent an "Urgent Device Correction" letters dated August 15, 2011 which included LOGIX OE screen illustrations of a representative neonate and adult patient, via first class mail to all affected customers. The letter identified the product, problem and actions to be taken. The customers were instructed to follow safe compounding practice, which includes verifying that the ingredient per units entered match the TPN prescription prior to preparation. Baxter requests that customers communicate this issue to all personnel responsible for LOGIX order entry and order authorization at their facility. Customers are instructed to retain a copy of the letter at each computer on which LOGIX OE software is installed. The customers were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Medical Information Services at 1-800-422-2751.