ABACUS TPN Calculation Software 의 리콜

Recall

67884

Class 1

Z-1566-2014

2014-04-02

2014-05-12

Terminated

United States

2016-01-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126581

1. 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.

Baxter 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 administration of a PN bag. Use of the ABACUS Software must comply with your facility's policies, procedures, and training, including verification that all information entered into the ABACUS Software is accurate and clinically appropriate. 2. To determine if any of these Issues are present in your current ABACUS configuration, please note the following immediate actions should be taken: "Double Salts: Baxter contacted all facilities installed by Baxter with ABACUS v3.1 to correct the Double Salts Issue via telephone between April 4, and April 16, 2014.To avoid the Double Salts Issue, a pharmacy installed with ABACUS v3.1 should 1) ensure the "Include non-electrolyte ion contributions in balance" checkbox is checked for all salt-based templates, and 2) compare the ordered amount of salts to the delivered amount on the Ions tab in ABACUS. "Sterile Water Added to TPN with Pre-Mix: Customer should ensure that all premix not intended for use on the compounder are marked as "Pre-Mix PN Solution" type in the Formulary. Customer should then check the template, under the "Infusion" tab, to ensure the "Infusion Mode" is set to "Pre-Mix (Cyclic)". "Premasol CaP04 Curve Data Points: Review Attachment 1 for information relevant to the use of calcium phosphate curves for Premasol 3% Dex 25