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 Pulmonary Embolism (1498); Stroke/CVA (1770); Dyspnea (1816); Paralysis (1997); Pneumonia (2011); Confusion/ Disorientation (2553); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

The involved device was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.Based on the available information, there is no indication that a malfunction occurred.A search of the complaint database revealed no other serious events associated with this device.

Event Description

A report was received on (b)(6) 2020 from the home therapy nurse (htn) of a (b)(6) year old female patient with a known medical history of asthma, diabetes, left lung lower lobectomy and end stage renal disease stating the patient experienced a stroke during hemodialysis therapy on (b)(6) 2020.Additional information was received on (b)(6) 2021 from the htn who stated that the patient was transported to hospital, having multiple syncopal episodes enroute and was admitted with shortness of breath, inability to move her left lower extremity and confusion.Examinations in the emergency department (ed) to establish a differential diagnosis included cranial and pulmonary ct scans both with and without contrast medium, perfusion head ct, electrocardiogram, chest xray and extensive laboratory testing including blood cultures.Compliance with medications taken prior to hospitalization could not be determined.Testing results showed no occlusion of the large cranial vessels and no intracranial hemorrhage.A small, distal pulmonary embolus of unspecified significance and origin was found as well as extensive atelectasis and pneumonia.Antibiotic therapy was initiated (ceftriaxone and azithromycin, nos) and the patient was transferred to the intensive care unit.Results of the ed workup led to the documented diagnoses of altered mental status, left leg weakness, pulmonary embolism and pneumonia.Details of the course of hospitalization and date of discharge were requested and were not provided.The htn stated that the physician considered the event unlikely related to the device or hemodialysis therapy.

• 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: 11228779
• MDR Text Key: 241236089
• Report Number: 3003464075-2021-00002
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 98