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); High Blood Pressure/ Hypertension (1908)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

The device was received for evaluation and passed testing that ensures functionality of the device and sensors.A review of the device history record confirmed the product was released meeting all quality criteria and manufacturing specifications.Factors outside the scope of nxstage therapy can impact the patient''s weight, these include but are not limited to the accuracy with which intake is recorded, the weighing techniques used, and the patient's comorbidities.Udi: (b)(4).

Event Description

A report was received on 02 sep 2020 from the home therapy nurse (htn) of a (b)(6) male with a medical history of hypertension, chronic hypoxemic respiratory failure, obesity, type ii diabetes chronic anemia and end stage renal disease, who stated insufficient fluid was removed and the patient experienced shortness of breath during hemodialysis treatment on (b)(6) 2020.The patient was admitted to hospital for fluid overload on (b)(6) 2020.Additional information was received 14-15 sep 2020 from the htn who stated the patient had experienced shortness of breath and insufficient fluid removal for several days prior to the event.The patient was admitted 2 sep 2020 with acute on chronic hypoxemic respiratory failure, secondary to pulmonary edema and fluid overload and uncontrolled hypertension.The course of hospitalization included investigation of elevated troponin and procalcitonin, antibiotics for suspected pneumonia, adjustment of blood pressure medication, noninvasive bipap ventilation and dialysis to control volume status.They received instruction regarding home hemodialysis treatments and weight management.Symptoms resolved, the patient improved and was discharged on (b)(6) 2020 to continue home hemodialysis treatments utilizing 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: 10606896
• MDR Text Key: 209209150
• Report Number: 3003464075-2020-00065
• 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: 09/30/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Weight: 140