ClearanceBrief
Recall Z-1566-2014 ยท NEP System/Device, Pharmacy Compounding

Baxter Corporation Englewood

ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order e

DateMay 12, 2014 (initiated Apr 2, 2014)
StatusTerminated
Reason1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v
Root causeSoftware design
ActionBaxter sent an Urgent Device Correction letter dated April 21, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. . 1. Follow safe compounding practice, which includes 1) using of the Summary button to verify the order against the calculated amounts prior to completing the order, 2) verifying that the ordered ingredients and quantities displayed in the software and printed on the Bag label and the Solution Formula label match the PN prescription prior to preparation, and 2) using a filter for admi
Quantity2034
DistributionWorldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia, Morocco, Oman, Qatar, Saudi Arabia, Slovenia, Slovakia, South Africa, Switzerlan
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.