MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-23 for PYXIS ANESTHESIA SYSTEM (PAS) PAS ES manufactured by Carefusion.
[106244404]
Based on system log files, the biometric finger scanner (bio-id) lost communication with the system. As programmed, the bio-id attempted to re-initialize but was unsuccessful resulting in a requires maintenance error. At this time, bd has requested the bio-id back for failure investigation.
Patient Sequence No: 1, Text Type: N, H10
[106244405]
Customer reports that users were unable to access intubation medications in the pyxis anesthesia system during an emergency c-section. The baby was sent to nicu and required respiratory intervention. The customer reported no permanent harm to the mother or baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2018-00001 |
| MDR Report Key | 7453133 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2018-04-23 |
| 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 | PHARMACIST |
| 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 | 2018-04-23 |
| Model Number | PAS ES |
| Catalog Number | PAS ES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2018-04-23 |