MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-28 for PRISMASATE 500 CC DIALYSIS SOLUTION manufactured by Gambro.
[17527854]
Two (2) prismasate dialysis solution bags for continuous renal replacement therapy by gambro -both were 5000cc each- split for pt. We had to remake the bags. Dose or amount: 5000cc. Frequency: continuous. Route: iv. Dates of: 2009. Diagnosis or reason for use: renal failure. P3 container cracked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014168 |
| MDR Report Key | 1570788 |
| Date Received | 2009-12-28 |
| Date of Report | 2009-12-28 |
| Date of Event | 2009-12-12 |
| Date Added to Maude | 2010-01-08 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMASATE 500 CC DIALYSIS SOLUTION |
| Generic Name | NONE |
| Product Code | FII |
| Date Received | 2009-12-28 |
| Lot Number | P9H368 |
| ID Number | 0733241403703 |
| Device Expiration Date | 2010-08-30 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-28 |