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

Model Number NX1000-3

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

Patient Problem Death (1802)

Event Date 10/01/2019

Event Type  Death  

Manufacturer Narrative

Udi#: (b)(4).There was no device malfunction.The log file was received for analysis and showed the device was functioning as designed and intended with no unexpected device behavior.Review of the log file showed the device successfully passed prime and alarms testing, the patient performed a full treatment and pressed the stop button at the end of treatment, which enables the patient to prepare to enter rinseback mode.The system remained in "ready for rinseback" mode for seven hours, until the patient was found.An autopsy has been ordered and nxstage has requested follow up with results.The device history record (dhr) for the cycler was reviewed and confirmed that the product was released having met all product design and acceptance requirements prior to release.A review of the complaint database revealed no other events of this nature with this device.Biocompatibility has been established.The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.

Event Description

A report was received on (b)(6) 2019 from the home therapy nurse (htn) of a (b)(6) year old male, stating the patient expired during a solo home hemodialysis treatment on (b)(6) 2019.Additional information was received on (b)(6) 2019 from the htn stating the patient was beginning the automated rinseback procedure via his central venous catheter at the time of the event.There was no indication of a device malfunction and the cause of death is not available.An autopsy has been ordered and nxstage has requested follow up with results.

• 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: 9246128
• MDR Text Key: 164007023
• Report Number: 3003464075-2019-00056
• 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: 01/01/2005,10/28/2019

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: NX1000-3
• Device Catalogue Number: CYC-D2E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• 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: 10/01/2019
• Initial Date FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR
• Patient Weight: 100