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

Model Number CAR-172-C

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411)

Event Date 03/19/2024

Event Type  Injury  

Event Description

A report was received on 26 mar 2024 from the home therapy nurse (htn) of a 55 year old male patient with a medical history including end stage renal disease, who stated the patent's blood pressure decreased (nos) which continued to worsen during a home hemodialysis treatment on 19 mar 2024.Treatment was terminated, rinseback was performed, and emergency medical services (ems) were contacted.Per the htn, the patient lost an unspecified amount of blood from an unclamped medication line and they were transported to hospital on (b)(6) 2024.Additional information was received on 27 mar 2024 from the htn stating the patient was admitted for hypotension and received a blood transfusion.Per the htn, the patient was discharged (b)(6) 2024 in stable condition with a diagnosis of convulsive syncope and continues therapy with the nxstage system.

Manufacturer Narrative

No product was received for evaluation.All devices must meet quality requirements and manufacturing specifications prior to release.The instructions for use states "check the system for blood and fluid leaks during treatment, and pay close attention to the blood line and access connections." all treatments must be administered under a physician's prescription and performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician so that alarms and harmful conditions can be responded to promptly.

• 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 ; 9784505276
• MDR Report Key: 19061462
• MDR Text Key: 339615752
• Report Number: 3003464075-2024-00059
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/08/2024

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: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 132 KG