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

Model Number NX1000-1

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

Patient Problems Anoxia (1711); Cardiopulmonary Arrest (1765); Cyanosis (1798); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 10/26/2020

Event Type  Death  

Manufacturer Narrative

The involved cycler has not been received for evaluation.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.Based on the available information, there is no evidence to indicate that a malfunction occurred.A search of the complaint database revealed no other serious events associated with this device.Udi #: (b)(4).

Event Description

A report was received on 26 oct 2020 from the home therapy nurse (htn) of a (b)(6) year old female with significant comorbidities including end stage renal disease, stating the patient experienced an adverse event (nos) during their first in-center hemodialysis treatment with the nxstage system on (b)(6) 2020.Additional information was received on 02-13 nov 2020 from the htn stating the patient became symptomatic within minutes of initiating treatment.Symptoms included shortness of breath, hypertension, cyanosis, abnormal respirations, and unresponsiveness.Nasal oxygen was applied and emergency medical services were summoned.During transport to hospital, the patient became pulseless and cardiopulmonary resuscitation (cpr) measures were initiated.The patient received bag valve mask oxygenation and was in pulseless electrical activity upon arrival to the emergency room (er) where they were intubated.Cpr continued and included 9 doses of epinephrine, 1 amp of calcium, 1 gram of magnesium, and defibrillation x3.Following return of circulation, the patient received 1 amp of bicarb and 125 mg of solu-medrol.The patient was admitted to the intensive care unit on mechanical ventilation and was diagnosed with cardiopulmonary arrest and anoxic brain injury.The patient was extubated, transitioned into comfort care, and expired on (b)(6) 2020.

• 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: 10891371
• MDR Text Key: 217921062
• Report Number: 3003464075-2020-00076
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050525
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 94