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

Model Number NX1000-1

Device Problems Unexpected Therapeutic Results (1631); Inadequate User Interface (2958)

Patient Problems Emotional Changes (1831); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

Event Date 05/02/2022

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) female patient with a medical history including diabetes and end stage renal disease, who stated she was unable to complete home hemodialysis treatment on (b)(6) 2022 due to issues with troubleshooting alarms.The patient was seen at the emergency department with symptoms of body aches, cramping, swollen feet and feeling "jumpy." additional information was received on (b)(6) 2022 from the home therapy manager (htm) who stated the patient has had ongoing issues with alarms occurring during treatment since on (b)(6) 2022.Upon terminating treatment early on (b)(6) 2022 without rinseback, the patient was advised by her clinic to be seen by urgent care to "be assessed," urgent care then instructed the patient to be seen at the emergency department because it had been several days since she last completed a successful treatment.The patient arrived to the emergency department on the evening of (b)(6) 2022 where she received successful hemodialysis treatment as well as intravenous (iv) calcium gluconate (1000mg), iv dextrose 50% (50ml), iv furosemide (40mg) and iv regular insulin (10 units).Per the htm, the patient has recovered without sequelae to resume in-center treatment until her replacement nxstage system is received.

• 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: 14488227
• MDR Text Key: 292503616
• Report Number: 3003464075-2022-00019
• 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: 05/24/2022

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: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 90 KG