MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-22 for NXSTAGE SYSTEM ONE SAK-304 manufactured by Nxstage Medical, Inc..
[100657010]
The device was not retained for investigation. The user guide provides instruction to maintain aseptic technique and warnings to follow instructions provided to prevent the risk of exposure to infectious diseases. A lot number was not identified. All available information supports that the product was functioning as designed and there was no malfunction. Biocompatibility of the device has been established. Nxstage medical considers this report closed. No additional information will be provided.
Patient Sequence No: 1, Text Type: N, H10
[100657011]
A report was received on 1 feb 2018 from the caregiver of a (b)(6) male who was not feeling well. The patient was hospitalized from (b)(6) 2017. Though requested, additional information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003464075-2018-00008 |
| MDR Report Key | 7288390 |
| Report Source | CONSUMER |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-01 |
| Date Added to Maude | 2018-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PAULA ROGALSKI |
| Manufacturer Street | NXSTAGE MEDICAL, INC 350 MERRIMACK STREET |
| Manufacturer City | LAWRENCE MA 01843 |
| Manufacturer Country | US |
| Manufacturer Postal | 01843 |
| Manufacturer Phone | 9786874700 |
| Manufacturer G1 | MEDIMEXICO S. DE R. L. DE C. V |
| Manufacturer Street | AV. VALLE IMPERIAL NO. 10523 PARQUE INDUSTRIAL VALLE SUR |
| Manufacturer City | TIJUANA 22180 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22180 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NXSTAGE SYSTEM ONE |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM |
| Product Code | FKR |
| Date Received | 2018-02-22 |
| Model Number | SAK-304 |
| Catalog Number | SAK-304 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization | 2018-02-22 |