MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-05 for NXSTAGE DIALYSIS CYCLER manufactured by Nxstage Medical, Inc..
| Report Number | MW5088795 |
| MDR Report Key | 8865571 |
| Date Received | 2019-08-05 |
| Date of Report | 2019-08-01 |
| Date of Event | 2019-08-01 |
| Date Added to Maude | 2019-08-06 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 DIALYSIS CYCLER |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2019-08-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Brand Name | NXSTAGE DIALYSIS CYCLER |
| Generic Name | SYSTEM, DIASYLATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2019-08-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Brand Name | NXSTAGE DIALYSIS CYCLER |
| Generic Name | SYSTEM, DIASYLATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2019-08-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Brand Name | NXSTAGE DIALYSIS CYCLER |
| Generic Name | SYSTEM, DIASYLATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2019-08-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-08-05 |