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

Model Number NX1000-1

Device Problem Air/Gas in Device (4062)

Patient Problems Dyspnea (1816); Muscle Weakness (1967); Dizziness (2194); Cognitive Changes (2551)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

The involved cycler was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.There was no indication of a device malfunction from the available information.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 (b)(6) 2022 regarding a (b)(6) year old male with a medical history including hypertension and end stage renal disease, who experienced air in the blood lines during hemodialysis therapy and terminated treatment, discarding the blood in the circuit (~191ml) on (b)(6) 2022.Additional information was received on 06 may 2022 from the home therapy nurse (htn) who stated the patient presented to hospital with shortness of breath (sob), weakness, inability to concentrate, and lightheadedness.The nurse stated that prior to admission, the patient¿s hemoglobin (hgb) was ¿within range¿ (value, date and time not provided).Lab tests at the hospital showed a hgb of 7.7 g/dl and the patient received 2 units of packed red blood cells (prbc).Although requested, dates of admission and hospital records were not provided.Following the event, the patient has resumed therapy 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
• MDR Report Key: 14337462
• MDR Text Key: 291237217
• Report Number: 3003464075-2022-00017
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2007
• 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): Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 74 KG