MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for 0.9% SODIUM CHLORIDE INJECTION, USP, 1000 ML manufactured by Baxter Healthcare Corporation.
[186304749]
The pressurized saline bag ruptured and leaked on the iabp console that was in the patient causing the iabp to become inoperable. The console was taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9844206 |
| MDR Report Key | 9844206 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-30 |
| Report Date | 2020-01-02 |
| Date Reported to FDA | 2020-01-02 |
| Date Reported to Mfgr | 2020-01-30 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | 0.9% SODIUM CHLORIDE INJECTION, USP, 1000 ML |
| Generic Name | CONTAINER, I.V. |
| Product Code | KPE |
| Date Received | 2020-03-17 |
| Lot Number | Y322875 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |