MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for PYXIS ES PYXIS MEDSTATION ES manufactured by Carefusion.
[45437830]
Complete system-wide downtime of all pyxis medstations (pyxis es platform) across six hospitals for 18 hours. During this downtime, the pharmacy technician has to physically go to each medstation and put it on critical override. This has been a recurrent issue and has been reported to the vendor (bd/carefusion). However, the vendor has yet to identify the root cause of the problem. During the systemwide downtime on (b)(6), the outage lasted 18 hours, there was a period of the outage during which the nurses in the icu at one of the hospitals were unable to access the medications in the medstations despite them being on critical override.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062280 |
| MDR Report Key | 5658712 |
| Date Received | 2016-05-12 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-05-10 |
| Date Added to Maude | 2016-05-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PYXIS ES |
| Generic Name | PYXIS |
| Product Code | LNX |
| Date Received | 2016-05-12 |
| Model Number | PYXIS MEDSTATION ES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-12 |