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

Model Number CAR-170-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Dizziness (2194); Loss of consciousness (2418)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

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. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions. Biocompatibility of the device has been established.

Event Description

A report was received on 09 oct 2021 from the home therapy nurse (htn) of a (b)(6) year old female with a medical history including diabetes, gastroparesis, hypertension and end stage renal disease, who stated the patient experienced an allergic reaction (nos) during a home hemodialysis treatment on (b)(6) 2021. Additional information was received on 12 oct 2021 from the htn who stated the patient became symptomatic approximately ninety minutes into treatment. Symptoms included decreased blood pressure (76/40 mmhg), dizziness, loss of consciousness and vomiting. A saline bolus was administered, rinseback was performed and emergency medical services were called. The patient declined transfer to hospital and recovered without further intervention.

• 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: 12646501
• MDR Text Key: 276845814
• Report Number: 3003464075-2021-00055
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 10877011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/18/2021 Patient Sequence Number: 1