MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-02 for PRISMASATE DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY 5000ML BAG BGK 2/0 6054352 manufactured by Gambro.
[1513647]
Prismasate dialysis solution for continuous renal replacement therapy two compartment bag separated by a peel seal. (bgk 2/0) 5000 ml bag. Lot # p9g304, exp date: 01/2011. When attempting to mix the product contents, the peel seal split open, resulting in the product contents pouring out of the bags. We have also been experiencing bag leakage with these products. We do not have the lot number or exp date for those bags. Concern about product content integrity/contamination with the leaking bags. Dose or amount: 3000 ml; frequency: per hour; route: iv. Dates of use: 2009. Diagnosis or reason for use: continuous renal replacement therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014012 |
| MDR Report Key | 1562922 |
| Date Received | 2009-12-02 |
| Date of Report | 2009-12-02 |
| Date of Event | 2009-12-02 |
| Date Added to Maude | 2009-12-28 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMASATE DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY 5000ML BAG |
| Generic Name | CVVH BAGS |
| Product Code | FII |
| Date Received | 2009-12-02 |
| Returned To Mfg | 2009-12-02 |
| Model Number | BGK 2/0 |
| Catalog Number | 6054352 |
| Lot Number | P9G304 |
| Device Expiration Date | 2011-01-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-02 |