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

Model Number NX1000-3-A

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

Patient Problems Cardiac Arrest (1762); Death (1802); Extubate (2402)

Event Date 11/17/2019

Event Type  Death  

Manufacturer Narrative

All product is released meeting all product design specifications and quality criteria. The available information does not indicate there was a device malfunction or that the patient death was attributed to nxstage product or therapy.

Event Description

A report was received on 18 nov 2019 from the home therapy nurse regarding patient a (b)(6) year old male with a medical history of hypertension, hydrocephalus, spina bifida and end stage renal disease who became unresponsive at an unspecified time while performing a home hemodialysis treatment without a caregiver present on (b)(6) 2019. The patient later expired at the hospital. Additional information was received on 25 nov 2019 from the home therapy nurse, who stated the caregiver found the patient unconscious and not breathing at an unspecified time during therapy on (b)(6) 2019. The caregiver commenced cpr and called ems who found the patient asystolic and continued resuscitative efforts including epinephrine enroute to the hospital. On arrival at the hospital the patient was given iv calcium gluconate and iv sodium bicarbonate, 2mg naloxone, epinephrine, was intubated and defibrillated once a shockable rhythm returned. The patient regained spontaneous circulation for an unspecified amount of time before deteriorating and subsequently expired due to cardiac arrest on (b)(6) 2019.

Manufacturer Narrative

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 complaint database revealed no other events of this nature for the reported serial number. Udi: (b)(4). H3 other text: placeholder.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 9403757
• Report Number: 3003464075-2019-00072
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Model Number: NX1000-3-A
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER, ROHS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 30 YR
• Patient Weight: 72
• Patient Outcome(s): Death