ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation

FDA device recall Z-0539-2014 · posted 2013-12-18 · Terminated

Recall details

Recalling firm

Baxter Corporation Englewood

Reason for recall

Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient's TPN order as a result of data corruption.

Action taken

Baxter sent an Urgent Device Correction letter dated December 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the patient order against the final bag label as part of the TPN acceptance procedure to ensure that the patient's TPN order is correct. Customers will be contacted by Baxter to arrange for installation of a software upgrade specific to their compounder's configuation. Customers were asked to acknowledge the receipt of this notification by completing the attached Customer Reply Form and return it to Baxter by fax to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. If the product was distributed to other facilities customers were instructed to notify end-user customers in accordance with their customary procedures. Customers with questions were instructed to call 1-800-678-2292. For questions regarding this recall call 800-422-9837.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LNX

Quantity affected

2,211

Distribution

Nationwide Distribution

Date initiated

2013-12-03

Date posted

2013-12-18

Date terminated

2015-10-16

Location

Englewood, CO