MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-06 for 3M RANGER 24200 manufactured by 3m Company.
[69479739]
During surgery, the bubble trap did not effectively expunge air, thereby causing an air embolism. A 24200 ranger fluid warmined set std flow 10/cs - 3mid - (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068316 |
| MDR Report Key | 6386796 |
| Date Received | 2017-03-06 |
| Date of Report | 2017-03-06 |
| Date of Event | 2016-12-16 |
| Date Added to Maude | 2017-03-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3M RANGER |
| Generic Name | FLUID WARMING SET STD FLOW |
| Product Code | KZL |
| Date Received | 2017-03-06 |
| Model Number | 24200 |
| Catalog Number | 24200 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | SAINT PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-06 |