MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for PRISMASATE manufactured by Baxter Healthercare Corporation.
[181764754]
A new bag of prismasate was squeezed for crrt. A small hole around the bottom opened and the fluid began to leak from the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093390 |
| MDR Report Key | 9774489 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-25 |
| Date Added to Maude | 2020-03-02 |
| 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 | PHARMACIST |
| 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 | PRISMASATE |
| Generic Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS |
| Product Code | KPO |
| Date Received | 2020-02-28 |
| Lot Number | 114905 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHERCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |