MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-15 for SYSTEM ONE WITH PUREFLOW SL manufactured by Nxstage.
[15812631]
Home hemodialysis patient running on nxstage machine. During the last 13 minutes of the treatment, husband of the patient heard a strange noise and found the patient unresponsive. Cpr performed but unable to revive patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036122 |
| MDR Report Key | 3820063 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-05-13 |
| Date of Event | 2014-04-29 |
| Date Added to Maude | 2014-05-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SYSTEM ONE WITH PUREFLOW SL |
| Generic Name | SYSTEM ONE WITH PUREFLOW SL |
| Product Code | FKR |
| Date Received | 2014-05-15 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE |
| Manufacturer Address | LAWRENCE 01843 01843 |
| Brand Name | SYSTEM ONE WITH PUREFLOW SL |
| Generic Name | SYSTEM ONE WITH PUREFLOW SL |
| Product Code | FKR |
| Date Received | 2014-05-15 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE |
| Manufacturer Address | LAWRENCE 01843 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-05-15 |