LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is i

FDA device recall Z-3276-2011 · posted 2011-09-23 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LHI

Quantity affected

95 units

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and the country of Canada.

Date initiated

2011-08-15

Date posted

2011-09-23

Date terminated

2017-01-05

Location

Round Lake, IL