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 |