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

Model Number NX1000-3

Device Problem Gas/Air Leak (2946)

Patient Problems Discomfort (2330); Cough (4457)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

There was no device malfunction.The device was received for evaluation and successfully passed testing, confirming proper functionality of the device and sensors, including the air detection sensors.Available log files were retrieved and analyzed which showed the cycler performed as designed and intended, alarming appropriately when alarm conditions were present.Per the log file review air alarms were present for 39 minutes prior to the patient event without evidence of air removal or troubleshooting.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.All information supports the device was functioning as designed and intended with no malfunction.The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns that treatment should only be performed by a trained and qualified person who must respond promptly to harmful conditions during treatment.Udi: (b)(4).

Event Description

A report was received on 11 oct 2021 from the nurse of a (b)(6) year old female with a medical history including type ii diabetes, polycystic kidney disease (anephric), hypertension, hypothyroidism and end stage renal disease, who stated the patient experienced coughing and noted air in the venous line approximately two hours into a hemodialysis treatment on (b)(6) 2021.Additional information was received on 12-15 oct 2021 from the nurse who stated the patient also experienced chest discomfort.The patient was placed on her left side, all lines were clamped and emergency medical services (ems) were called.Upon ems arrival, the patient was given 2l of oxygen, transported to hospital and admitted for observation.The patient was discharged on (b)(6) 2021 to resume therapy with the nxstage system one.

• 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
• MDR Report Key: 12743725
• MDR Text Key: 280053916
• Report Number: 3003464075-2021-00063
• 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: 11/03/2021

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: Health Professional
• 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: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 78