MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Model Number SAK-304

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• 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: 7288390
• MDR Text Key: 100657010
• Report Number: 3003464075-2018-00008
• Device Sequence Number: 1
• Product Code: FKR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SAK-304
• Device Catalogue Number: SAK-304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 107