ClearanceBrief
Recall Z-2646-2023 ยท BRY Cabinet, Table And Tray, Anesthesia

CareFusion 303, Inc.

BD Pyxis MedBank MedPass Software, REF: 139088-01

DateSep 28, 2023 (initiated Aug 18, 2023)
StatusOpen, Classified
ReasonAfter dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.
Root causeDevice Design
ActionOn 8/18/23, correction notices were mailed to directors of Biomedical Engineering/Risk Management/Nursing/Pharmacy and distributors. They were asked to take the following actions: 1) Remind users that affected devices do not replace the electronic (or paper) patient record, specifically the medication order, which will remain accurate and serves as the source of truth for medication administration. Nursing best practice is to confirm the 5 rights of medication orders prior to administration. Some inpatient psychiatric units also utilize barcode medication administration (BCMA) which may dete
Quantity37
DistributionUS: FL, MI, KS
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.