MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for NXSTAGE PUREFLOW B SOLUTION RFP-404 manufactured by Nxstage Medical, Inc..
[141442276]
Upon activating the replacement dialysate bag, the back of the bag broke open. A replacement bag had to be ordered to continue with continuous veno-venous hemodialysis (cvvhd).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8498925 |
| MDR Report Key | 8498925 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-03-21 |
| Report Date | 2019-03-22 |
| Date Reported to FDA | 2019-03-22 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 PUREFLOW B SOLUTION |
| Generic Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| Product Code | KPO |
| Date Received | 2019-04-10 |
| Model Number | RFP-404 |
| Lot Number | Q1812094 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |