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

Model Number NX1000-3-A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Pneumonia (2011); Pulmonary Edema (2020); Respiratory Distress (2045)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) was performed and 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 23 nov 2020 from the home therapy nurse (htn) of a (b)(6) year old male patient with a medical history including end stage renal disease on dialysis, essential hypertension, focal segmental glomerulosclerosis, anemia in end stage renal disease, retained bullet, pneumonia and insomnia, stating the patient was admitted to hospital after an insufficient amount of fluid was removed during a home hemodialysis treatment on (b)(6) 2020.Additional information was received 25 nov - 10 dec 2020 from the htn stating insufficient fluid removal had been ongoing (no dates or details provided) and the patient was hospitalized with respiratory difficulty, pulmonary edema, and hemoptysis following hemodialysis therapy on (b)(6) 2020.The patient received hemodialysis treatments and unspecified antibiotics while hospitalized and blood cultures revealed no growth.The patient¿s diuretic medication (nos) was increased from 25mg/day to 50mg/day and the patient was discharged on (b)(6) 2020 with a diagnosis of atypical pneumonia.

• 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: 11015495
• MDR Text Key: 221736353
• Report Number: 3003464075-2020-00081
• 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: 12/15/2020

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-A
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 89