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 Dyspnea (1816); Edema (1820); High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020); Hypervolemia (2664)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

No product was received for evaluation.A review of the device history record confirmed the product was released meeting all quality criteria and manufacturing specifications.Udi: (b)(4).

Event Description

A report was received on 09 jan 2020 from the nurse of a (b)(6) year old male patient with a medical history including end stage renal disease, type ii diabetes, morbid obesity, anemia, hypertension and previous pneumonia who stated the patient was hospitalized due to insufficient fluid removal during hemodialysis treatments.Additional information was provided 14-23 jan 2020 from the home therapy nurse (htn) who stated the patient presented to emergency room on (b)(6) 2020 with shortness of breath, peripheral edema, pulmonary edema, uncontrolled hypertension and fluid overload.He was admitted to hospital, given intravenous nicardipine (5mg/hr) and lasix (80mg iv stat) and daily ultrafiltration therapy.Symptoms resolved and the patient was discharged in stable condition without sequelae on (b)(6) 2020 to resume treatment with the nxstage system.

• 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: 9646534
• MDR Text Key: 188242338
• Report Number: 3003464075-2020-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• 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: 01/01/2005,01/30/2020

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
• 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
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 118