MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for BLENDER 10047A manufactured by Carefusion Corporation.
[141468239]
Patient is on ecmo-post oxygenator pao2 reading 70, oxygen tubing/filter changed without improvement. Changed post oxygenator pao2 greater than 500. Blender dial knob found to be loose. Analyzer check reading = 21%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8499538 |
| MDR Report Key | 8499538 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-02-11 |
| Report Date | 2019-02-27 |
| Date Reported to FDA | 2019-02-27 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | BLENDER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2019-04-10 |
| Model Number | 10047A |
| Catalog Number | 10047A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 18 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION CORPORATION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |