Recall Z-1579-2023 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
| Date | May 11, 2023 (initiated Apr 5, 2023) |
| Status | Open, Classified |
| Reason | Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication. |
| Root cause | Software Design Change |
| Action | On 4/5/23, correction notices were distributed to Biomedical Engineering, Risk Management, Nursing, Pharmacy Directors who were informed of the following: 1) Remind users that automated dispensing cabinet devices are not a replacement for the medical record (e.g., medication orders, medication administration record (MAR), and patient allergy information) and are not to be relied on as the source of truth for medication administration. Consult the hospital medical record before removing any medication. 2. Please ensure this letter is forwarded to applicable facilities if devices have been tran |
| Quantity | 1,474 |
| Distribution | US Nationwide distribution in the states of KS, NY, NC, LA, MA, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.