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 2016-04-20 for PYXIS ANESTHESIA SYSTEM (PAS) PAS ES manufactured by Carefusion.
[43149955]
Customer advocacy reviewed the log files for the device and found the drawer timed out and failed close when the medication was selected by the provider and drawer physically would not open. The drawer was recovered and refilled after the case by pharmacy. No other errors were noted in the log files. Field service inspected the drawer and found no defects with the drawer. Therefore, it is determined the most likely cause is one of the prefilled syringes housed in the drawer caused a medication jam preventing the drawer from opening.
Patient Sequence No: 1, Text Type: N, H10
[43149956]
Anesthesiologist reports minidrawer on pyxis anesthesia system would not open when attempting to obtain a second dose of succinylcholine to intubate a difficult airway. The provider reported an alternative medication of propofol was administered and the patient's airway remained unable to be intubated. The patient required ambu bagging for ventilation while a second does of succinylcholine was retrieved by another provider in an alternate location. The provider reported no permanent harm to the patient and no change in vital signs. Bd became aware of the serious injury on 04/06/2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2016-00002 |
| MDR Report Key | 5591300 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-20 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-03-24 |
| Date Mfgr Received | 2016-03-24 |
| Device Manufacturer Date | 2015-10-13 |
| Date Added to Maude | 2016-04-20 |
| 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 |
| 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 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 | 2016-04-20 |
| Model Number | PAS ES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2016-04-20 |