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

Model Number NX1000-3

Device Problem Disconnection (1171)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 08/01/2020

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 device met all quality criteria and manufacturing specifications prior to release.The reported event is attributed to a patient use error with their central venous catheter (cvc).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) 2020 from a home therapy nurse (htn), stating a (b)(6) year old female with a medical history of hypertension and end stage renal disease, was found cold and unresponsive with unclamped central venous catheter (cvc) lines, disconnected hemodialysis bloodlines, and a ¿puddle¿ of blood on the floor at an unspecified time while performing home hemodialysis treatment on (b)(6) 2020.Additional information was received (b)(6) 2020 from the htn stating the patient performed a home hemodialysis treatment without a care partner present and had disconnected their cvc from the nxstage system at the time of the event.Per the htn, the amount of blood loss was unknown, emergency services were called, and the patient was pronounced deceased on (b)(6) 2020.The htn stated that treatment details, amount of blood loss, and cause of death were unavailable.

• 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: 10467495
• MDR Text Key: 204879791
• Report Number: 3003464075-2020-00058
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• 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: 01/01/2005,08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• 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
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• 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): Death
• Patient Age: 48 YR
• Patient Weight: 72