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 Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Nausea (1970); Dizziness (2194); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

The product was received for evaluation and successfully passed testing, no leaks or occlusions were observed and all luers and connectors were intact with no compromised integrity found.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.The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly.

Event Description

A report was received on 16 aug 2021 from the caregiver (cg) of a (b)(6) male with a medical history including diabetes and end stage renal disease, who stated the patient experienced shivers and a fever (99 f) during a home hemodialysis treatment on (b)(6) 2021.Treatment was terminated and rinse back was successfully performed.The patient¿s temperature continued to rise (104.5 f), blood pressure increased (180/62mmhg), and the patient experienced nausea, headache, and dizziness.911 was called and the patient was transported to the hospital and admitted.Additional information was received on 24 aug 2021 from the home therapy nurse (htn) who stated the patient presented to the emergency room with shortness of breath, cough, and general weakness, which had been present for the past week.The patient was treated empirically with antibiotics per hospital protocol, though blood culture results were negative, and white blood cell count was within normal limits.Patient has a history of noncompliance, noting two missed rounds of hemodialysis in the previous week, and a recent diabetic foot injury treated with two rounds of antibiotics.Per the htn, symptoms resolved, and the patient discharged himself from the hospital against medical advice on (b)(6) 2021 to continue treatments at the dialysis facility prior to returning to home hemodialysis.

• 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: 12459435
• MDR Text Key: 271000763
• Report Number: 3003464075-2021-00041
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2021

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: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 10677030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• 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: 57 YR
• Patient Weight: 140