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 Syncope (1610); Fall (1848); Loss of consciousness (2418)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been received for evaluation and a serial number was not provided.Without a serial number, a review of the device history record (dhr) cannot be performed.There is no information to indicate that a malfunction or unexpected device behavior occurred.Although requested, no further information has been provided.

Event Description

A report was received on 12 may 2020 from a health care professional, regarding a patient weighing 72kg with end stage renal disease who lost consciousness and fell during a home hemodialysis treatment on (b)(6) 2020.Treatment was terminated with partial rinseback and the patient was disconnected from the cycler.Emergency services transported the patient to hospital where they were diagnosed with syncope and hospitalized.The patient's condition is improving.Treatment details, date of discharge and discharge diagnosis were requested and have not 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: 10134353
• MDR Text Key: 194604354
• Report Number: 3003464075-2020-00027
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 72