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

Model Number CAR-172-C

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Pericardial Effusion (3271); Syncope/Fainting (4411)

Event Date 12/01/2021

Event Type  Injury  

Event Description

A report was received on 02 feb 2022 from the nurse of a (b)(6) male with extensive comorbidities including a recent hypersensitivity type reaction, anemia, arterio-venous malformations, cirrhosis with ascites, anxiety, hypertension, diabetes and end stage renal disease, who stated the patient experienced shortness of breath and a syncopal episode immediately upon beginning a hemodialysis treatment on (b)(6) 2021. Per the nurse, the patient was taken to the emergency department and admitted to hospital. Additional information was received on (b)(6) 2022 from the nurse who provided hospital records showing the patient also became hypertensive in the emergency department. Workup at the hospital included chest ct and transthoracic echocardiogram that diagnosed a pericardial effusion which was treated with creation of a pericardial window and removal of 300ml of fluid. Per the hospital record, the patient was discharged in stable condition on (b)(6) 2021 with a diagnosis of pericardial effusion.

Manufacturer Narrative

The patient experienced an adverse event with the same device model number on 2 additional dates. The event on (b)(6) 2021 is documented in mfr report # 3003464075-2022-00006. The event on (b)(6) 2022 is documented in mfr report # 3003464075-2022-00005. 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.

• 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: 13516178
• MDR Text Key: 287329704
• Report Number: 3003464075-2022-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 10877005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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: 02/11/2022 Patient Sequence Number: 1