MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-27 for NXSTAGE SYSTEM ONE SAK-404 manufactured by Nxstage Medical, Inc..
[73893982]
The device has not been received for investigation. A lot number was not identified; therefore, no device history review (dhr) could be performed. There is no indication that the device was related to the reported event. The user guide warns: hemodialysis may result in significant changes in the blood concentration of electrolytes and glucose and in the patient? S volume status. Appropriate monitoring of the patient? S hemodynamic, fluid, electrolyte, and acid-base balance should be performed regularly, per physician orders, to ensure appropriate response to therapy. Failure to do so could result in inappropriate therapy for the patient.
Patient Sequence No: 1, Text Type: N, H10
[73893983]
A report was received on (b)(6) 2017 from the caregiver of a (b)(6) male patient with an ongoing history of hyperkalemia, who had received standard home hemodialysis treatment on (b)(6) 2017. On (b)(6) 2017 the patient experienced weakness, shortness of breath and shaking. The patient was transported to the hospital and experienced a cardiac arrest enroute. He was admitted and remained hospitalized until (b)(6) 2017 when he was transferred to a rehabilitation facility until (b)(6) 2017. The patient was released from the rehabilitation facility in stable condition, returning to standard home hemodialysis. A discharge diagnosis was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003464075-2017-00026 |
| MDR Report Key | 6526662 |
| Report Source | CONSUMER |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-03-26 |
| Date Mfgr Received | 2017-04-14 |
| Date Added to Maude | 2017-04-27 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 2017-04-27 |
| Model Number | SAK-404 |
| Catalog Number | SAK-404 |
| 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; 2. Life Threatening | 2017-04-27 |