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

Model Number NX1000-3-A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Anemia (1706); Fall (1848); Head Injury (1879); Swelling (2091); Dizziness (2194); Loss of consciousness (2418); Sweating (2444); Blood Loss (2597)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

No product was received for evaluation.A review of the device history record (dhr) of the reported serial number confirmed no related defects were found during the manufacturing and the device was released for distribution having met all product design requirements.(b)(4).Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2018 from a (b)(6)-year-old male with a medical history including anemia, hypertension and type ii diabetes who reported that he elected to remove more fluid than prescribed during a solo home hemodialysis treatment on (b)(6)2018 and he became sweaty, dizzy, lost consciousness, fell and hit his head.A large unspecified amount of blood was noted shortly after treatment (nos) around the hemodialysis device.Additional information was received from the home therapy nurse (htn) on (b)(6) 2018 stating the amount of blood loss could not be determined.The patient attended the hospital on (b)(6) 2018 where he received a blood transfusion for worsened anemia of 6.9 g/dl (previous value not given).Mild right frontal scalp soft tissue swelling was evaluated via a ct scan which showed no acute intracranial abnormality and the patient was released without sequelae to continue hemodialysis therapy.

• 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: 8241378
• MDR Text Key: 132853697
• Report Number: 3003464075-2019-00001
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,01/11/2019

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
• 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: 12/22/2018
• Initial Date FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 120