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

Model Number NX1000-16

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

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

The cycler was not received for evaluation and no defect was found during evaluation of the involved cartridge.All devices must meet quality requirements 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 all treatments must be administered under a physician''s prescription and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.The patient experienced an adverse event with the same device model number on an additional date.The event on (b)(6) 2023 is documented in mfr report #3003464075-2023-00105.Udi: (b)(4).

Event Description

A report was received on 03 nov 2023 from the home therapy nurse (htn) of a 78 year old female patient recently discharged from hospital with a complex medical history including end stage renal disease, who stated the patient coded during an in-center hemodialysis treatment on 03 nov 2023.The patient was transported to hospital and admitted.Additional information was received on (b)(6) 2023 from the htn who stated approximately 25 minutes into treatment the patient became unresponsive, experienced seizure like activity, and went into cardiac arrest.The patient was resuscitated and transported to hospital and her potassium was noted to be out of range, value not provided.Per the htn the patient has recovered and was discharged (b)(6) 2023.No details of the hospitalization were provided.Following the event the patient changed to a different manufacturer for hemodialysis treatments.

• 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: 18246254
• MDR Text Key: 329482805
• Report Number: 3003464075-2023-00106
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170469
• 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: 12/01/2023

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: Health Professional
• Device Model Number: NX1000-16
• Device Catalogue Number: CYCLER VERSIHD 1.0, NO NIBP
• Device Lot Number: 38791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2019
• 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
• Patient Age: 78 YR
• Patient Sex: Female