MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-27 for PRISMAFLEX NA manufactured by Gambro Renal Products, Inc..
[1223524]
Crrt (continuous renal replacement therapy) machine set for zero fluid removal. 109 cc removed. Patient observed. Did not notice any other discrepancies rest of shift, nor did following shift. Biomed notified following day and given exact hr of incident. Discussed situation very briefly to crrt (continuous renal replacement therapy) md.
Patient Sequence No: 1, Text Type: D, B5
[1241788]
Crrt (continuous renal replacement therapy) machine set for zero fluid removal. 109 cc removed. Patient observed. Did not notice any other discrepancies rest of shift, nor did following shift. Biomed notified following day and given exact hr of incident. Discussed situation very briefly to crrt (continuous renal replacement therapy) md.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1496305 |
| MDR Report Key | 1496305 |
| Date Received | 2009-09-27 |
| Date of Report | 2009-09-26 |
| Date of Event | 2009-07-29 |
| Report Date | 2009-09-26 |
| Date Reported to FDA | 2009-09-27 |
| Date Added to Maude | 2009-10-08 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX |
| Generic Name | HEMODIALYSIS, CRRT |
| Product Code | MQS |
| Date Received | 2009-09-27 |
| Model Number | PRISMAFLEX |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 10810 WEST COLLINS AVENUE LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-27 |