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

Model Number NX1000-3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 03/03/2018

Event Type  Death  

Manufacturer Narrative

The device has not been received for evaluation.The device history record (dhr) for the cycler was reviewed and revealed that the product was released having met all product design and acceptance requirements prior to release.The nxstage system one user guide provides information regarding risks associated with dialysis treatments and states that a trained and qualified person must observe all treatments so that alarms and harmful conditions can be responded to promptly.Udi number: (b)(4).

Event Description

A report was received on 05 mar 2018 from the home therapy nurse (htn) regarding a (b)(6) male who experienced a hypotensive episode and lost consciousness during a standard hemodialysis treatment on (b)(6) 2018.The nurse stated the patient lost an unspecified amount of blood due to the central venous catheter being dislodged by the patient during therapy.Additional information received from the htn on 26 mar 2018 revealed that emergency services were contacted and resuscitative efforts were commenced.The patient was taken to the hospital where he subsequently expired.The nurse stated the cause of death was cardiac arrest.

• 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 ; 9786874700
• MDR Report Key: 7378909
• MDR Text Key: 103739461
• Report Number: 3003464075-2018-00015
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR