MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-03 for PYXIS ANESTHESIA SYSTEM (PAS) PAS4000 manufactured by Carefusion.
[46569731]
Carefusion received a medwatch (sus mw5061518) on may 9, 2016 from (b)(6) of (b)(6). The report date on the medwatch lists (b)(6) 2016. On (b)(6) 2016 (b)(6) from (b)(6) hospital in (b)(6) opened a case with carefusion documenting the same incident. A carefusion field service technician went on site attempted to replicate the issue without success. The mini drawer functioned correctly. Neither report alleges patient harm.
Patient Sequence No: 1, Text Type: N, H10
[46569732]
Customer reports that a mini drawer on a pyxis anesthesia system 4000 did not function properly causing medications in other drawers to be unavailable. The customer was able to retrieve mediations from a nearby device. No patient harm reported as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2016-00003 |
| MDR Report Key | 5698313 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-03 |
| Date of Report | 2016-06-03 |
| Date of Event | 2016-04-03 |
| Date Mfgr Received | 2016-04-03 |
| Device Manufacturer Date | 2014-02-05 |
| Date Added to Maude | 2016-06-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ALLISON SUAREZ |
| Manufacturer Street | 10020 PACIFIC MESA BLVD. |
| Manufacturer City | SAN DIEGO, CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586174995 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 10020 PACIFIC MESA BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PYXIS ANESTHESIA SYSTEM (PAS) |
| Generic Name | AUTOMATED DISPENSING CABINET (ADC'S) |
| Product Code | BRY |
| Date Received | 2016-06-03 |
| Model Number | PAS4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-03 |