MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS

Model Number RFP-204

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Nausea (1970); Respiratory Distress (2045); Alteration In Body Temperature (2682)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

The product was not retained for investigation.The certificate of analysis was reviewed and met all requirements in the manufacturing process prior to release with no related defects.Biocompatibility of the device has been established.Allergic reaction is a well documented potential risk associated with dialysis treatments.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on 22-june-2016 regarding a (b)(6) year old female patient with a medical history of end stage renal disease.On (b)(6) 2016 within 13 minutes of the start of dialysis treatment with the involved dialysate the patient experienced shortness of breath, cephalalgia, nausea and increased temperature.Symptoms resolved without medical intervention once therapy was ceased.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• Manufacturer (Section G): MEDIMEXICO S. DE R. L. DE C. V; av. valle imperial no. 10523; parque industrial valle sur; tijuana 22180 ; MX 22180
• Manufacturer Contact: paula rogalski ; nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9786874700
• MDR Report Key: 5806798
• MDR Text Key: 49944504
• Report Number: 3003464075-2016-00025
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: RFP-204
• Device Catalogue Number: RFP-204
• Device Lot Number: Q1604136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 46