MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for PRESSURE BAG manufactured by Carefusion 303, Inc..
[138663484]
Patient went to mri with aline infusing with pressure bag. Aline did not have transducer attached due to it being mri incompatible per mri tech. Rn noticed that the entire bag of fluid had infused into patient during procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8416141 |
| MDR Report Key | 8416141 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-02-26 |
| Report Date | 2019-02-12 |
| Date Reported to FDA | 2019-02-12 |
| Date Reported to Mfgr | 2019-03-13 |
| Date Added to Maude | 2019-03-13 |
| 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 | PRESSURE BAG |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2019-03-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 303, INC. |
| Manufacturer Address | 10020 PACIFIC MESA BLVD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |