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

Model Number NX1000-1

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

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Abdominal Cramps (2543); Hematuria (2558)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

The cycler was not provided for evaluation.A device history record (dhr) review was conducted for the cycler and the involved cartridge which met all manufacturing requirements and specifications prior to release of the unit.The nxstage system one user guide includes hemolysis as a potentially risk associated with dialysis therapy and states that an underlying medical condition or medication may cause hemolysis or alter normal effluent appearance.Udi: (b)(4).Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2019 from the nurse of a (b)(6) male with a medical history significant for anemia and coagulation deficiency, who experienced high blood pressure (bp), cramping, and headache during a home hemodialysis treatment on (b)(6) 2019.After treatment was terminated the patient observed blood in his urine and was hospitalized later that day.Additional information was received (b)(6) ¿ (b)(6) 2019 from the htm stating the patient was discharged on (b)(6) 2019 with a diagnosis of anemia and hemolysis and continues to perform hemodialysis treatments using nxstage products and therapy.Additional information has been requested and has not been received.

• 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: 8609586
• MDR Text Key: 145036031
• Report Number: 3003464075-2019-00015
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050525
• 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: 01/01/2005,05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 69