MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-23 for NXSTAGE SOLUTION 4K manufactured by Nxstage Medical, Inc..
[176420059]
Our entity utilizes nxstage solutions for our continuous renal replacement fluids. We utilize 0k/2k/ or 4k solutions depending on the pt's serum potassium level. The concern is that although the cardboard boxes that contain the solution have a different color label to highlight the differences in fluids, the bags themselves can be easily mistaken given lack of defining features. In essences, these are look alike medication. The concern is that the wrong crrt fluid could be hung and significantly affect a pt's electrolytes. What would be ideal is if the bags themselves could be color coded or improved identification of the varying potassium amounts. The different fluids (4k versus 2k). (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092463 |
| MDR Report Key | 9627081 |
| Date Received | 2020-01-23 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| 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 | NXSTAGE SOLUTION 4K |
| Generic Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| Product Code | KPO |
| Date Received | 2020-01-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Brand Name | NXSTAGE SOLUTION 2K |
| Generic Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| Product Code | KPO |
| Date Received | 2020-01-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-23 |