Automated Medication Dispenser Software Bug Causes Incorrect Bin Labels
BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a high-risk medical device used in medication dispensing. No illnesses or injuries have been reported; however, the software defect creates a direct risk of medication dispensing errors. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
CareFusion 303, Inc. is recalling 12 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P automated medication dispensing cabinets (model reference 169-94, software version 3.9.1.9) distributed nationwide across the United States. The recalled units contain a software defect that causes an incorrect medication bin location to be printed on restock labels.
When restock labels are printed for medications stored in the dispensing cabinet, the label may indicate the wrong bin location for the medication. This labeling error could cause healthcare personnel to access or restock medications from an incorrect bin location.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- mis-labeling
- software-defect
Distribution
Distributed nationwide across the United States.
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