MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-03 for NXSTAGE SYSTEM ONE SAK-301 manufactured by Nxstage Medical, Inc..
[69009807]
The product was not retained for investigation. A device history review (dhr) was performed and no defects were found during the manufacturing of the reported lot. Biocompatibility has been established. There is no information to indicate that a malfunction occurred. The nxstage user guide provides warning to always use aseptic technique when handling connections. Touching these surfaces may make them non-sterile, which may cause patient infection. Nxstage medical considers this report closed. No additional information will be provided.
Patient Sequence No: 1, Text Type: N, H10
[69009808]
It was reported by the patient's home therapy nurse that a (b)(6) female patient was treating in center on (b)(6) 2017. Approximately 2 hours after treatment commenced, the patient developed fever and chills. The patient was transported to the hospital and was admitted on (b)(6) 2017. The physician documented in the medical records that the patient was very unstable, unresponsive, was intubated and placed on mechanical ventilation. The patient was hypotensive requiring three "pressors" (vasopressors), received blood transfusions (unspecified), was treated with antibiotics and was placed on continuous renal replacement therapy (crrt). Additional documentation by the physician stated that the patient had severe sepsis secondary to citrobacter koseri, likely associated with the right (r) renal stones and colitis seen in ct imaging. The physician had noted there was bleeding from the right femoral vascath and this may have been a secondary source of infection. The physician recommended removal of the femoral line. The patient died in the hospital on (b)(6) 2017. The nurse reported that the cause of death was sepsis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003464075-2017-00012 |
| MDR Report Key | 6375935 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-03 |
| Date of Event | 2017-02-07 |
| Date Mfgr Received | 2017-02-10 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2017-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 2017-03-03 |
| Model Number | SAK-301 |
| Catalog Number | SAK-301 |
| Lot Number | 60679273 |
| ID Number | +M535SAK3010/$$0518606792739 |
| Device Expiration Date | 2017-05-01 |
| 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. Death; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention | 2017-03-03 |