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 Apnea (1720); Death (1802); Exsanguination (1841); Cognitive Changes (2551); Loss Of Pulse (2562)

Event Date 11/07/2019

Event Type  Death  

Manufacturer Narrative

The cycler was received for evaluation and passed all testing with no trouble found.A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.A review of the log file for the date of the event was consistent with needle dislodgement and there was no device malfunction.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.Udi #: (b)(4).

Event Description

A report was received on (b)(6) 2019 from the home therapy nurse (htn) regarding a (b)(6) year old male with end-stage renal disease, type ii diabetes, hypertension, peripheral vascular disease, coronary artery disease, mitral regurgitation, and hernia repair, who expired during a home hemodialysis treatment on (b)(6) 2019.Additional information was received on 18-26 nov 2019 from the home therapy manager (htm) stating the patient treated without the care partner present for an unspecified amount of time and was found pulseless and apneic with an estimated 3-4l blood loss.Resuscitation included chest compressions, intubation, multiple doses of iv epinephrine and attempts at defibrillation, intravenous amiodarone 450mg, calcium chloride 1g, bicarb 1amp and intraosseous saline 250ml.Resuscitative measures were unsuccessful and the patient was pronounced deceased at 1650hrs on (b)(6) 2019.Per physician, the cartridge venous line had been disconnected and the dialysis port was open with the cause of death suspected suicide from hemorrhage due to their mental health status after being denied a kidney transplant.

• 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: 9453513
• MDR Text Key: 170339253
• Report Number: 3003464075-2019-00075
• 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: 01/01/2005,12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Device Catalogue Number: NXSTAGE SYSTEM ONE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/11/2019
• Date Device Manufactured: 08/28/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 124