Device product
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Z-1847-2014
Product summary
- Event
- Event 68256
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42
- Official record key
device-enforcement:Z-1847-2014
Official wording
Reason: Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.
Code information: Product Code: 8300-0167, 8300-0168, 8300-0169
Distribution pattern: US Nationwide Distribution and the state of VA.
Derived failure modes
-
Device software or design
Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may