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 Death (1802); Exsanguination (1841)

Event Date 08/27/2019

Event Type  Death  

Manufacturer Narrative

The device was not received for evaluation.A review of the device history record confirmed the device was released meeting all manufacturing specifications and quality criteria.The user guide states a trained and qualified person must observe all treatments so that alarms and harmful conditions can be responded to promptly.A patient should not dialyze alone, even if they are trained and qualified.Udi: (b)(4).

Event Description

A report was received on 27 aug 2019 from the home therapy nurse (htn) regarding a (b)(6) year old male with a medical history of glomerulonephritis and end-stage renal disease, stating the patient expired at an unspecified time during a standard home hemodialysis treatment, likely due to exsanguination and treating without their care partner present.Additional information received on 28 aug 2019 from the htn confirmed the care partner was not present at the time of the event.Although requested, no additional information has been provided.

• 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: 9099309
• MDR Text Key: 159408069
• Report Number: 3003464075-2019-00048
• 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: 01/01/2005,09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E
• 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: 08/27/2019
• Date Device Manufactured: 09/24/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 109