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

Model Number NX1000-3

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

Patient Problems Stroke/CVA (1770); Weakness (2145)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

A device serial number was not provided and the device was not returned for evaluation.Without a serial number, a review of the device history record (dhr) is unable to be performed.All product is released having met all manufacturing specifications and quality requirements.The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly.Per the healthcare professional, the reported event is likely related to the patient''s comorbidities and recent episode of weakness.The diagnosis of ''small vessel stroke'' is compatible with complications of hypertension and unlikely the result of a dialysis treatment.

Event Description

A report was received on (b)(6) 2020 from a 62 year old male patient with a medical history of carcinoma, hypertension, previously suspected angina in (b)(6) 2020 (nos), gout, sleep apnea, and end stage renal disease, who stated he lost consciousness while terminating a standard home hemodialysis treatment and returning his blood manually on (b)(6) 2020.The patient stated he suffered a stroke and was admitted to hospital.Additional information was received on (b)(6) 2020 from the healthcare professional (hcp) stating the patient was admitted to hospital on (b)(6) 2020 with a diagnosis provided by a neurologist of small vessel stroke with ¿severe deficit of left arm and legs¿.Per the hcp, the event is likely related to the patient''s comorbidities and recent episode of weakness.The details of hemodialysis treatment and course of hospitalization were not provided.The patient was discharged to a rehabilitation facility on (b)(6) 2020.

• 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 ; 9784505276
• MDR Report Key: 10713174
• MDR Text Key: 212348268
• Report Number: 3003464075-2020-00070
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2020

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: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 115