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

Model Number CAR-170-C

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Anxiety (2328)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

A lot number was not provided.No product was returned for investigation.There is no information to indicate that a malfunction occurred.The user guide includes allergic reaction as a potential risk associated with dialysis treatments and also includes warnings to monitor for potential allergic reactions.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2017 of an (b)(6) female patient who experienced hypertension, shortness of breath and anxiety approximately 30 minutes after standard home hemodialysis therapy commenced on (b)(6) 2017.The caregiver ended treatments early due to symptoms.The patient treated in center on (b)(6) 2017 and received oxygen during the treatment.The patient again experienced the same symptoms.The patient was hospitalized on (b)(6) 2017 to dialyze on a different system and was reported to be asymptomatic during treatment.The patient was released on (b)(6) 2017 and has resumed home hemodialysis using a different dialysis filter with no report of further symptoms.

• 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: 6391080
• MDR Text Key: 69486386
• Report Number: 3003464075-2017-00013
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140526
• 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: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• 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: 82 YR
• Patient Weight: 74