
Baxter International · Model EXACTAMIX
Designed for cosigner validation of right drug/right port, the once daily set-up includes a Prime and Verify process. Helps reduce the need for manual additions by pumping volumes as low as 0.2 mL. Produces a 3L patient-ready TPN bag in approximately four minutes. Facilitates compliance with detailed reporting on calibration activities, pumping accuracy and individual patient formulas.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Potential ability to leak once used for compounding.
Potential ability to leak once used for compounding.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which could be delivered into the next bag.
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