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

Model Number NX1000-1

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Anemia (1706); Fatigue (1849); Hemorrhage/Bleeding (1888); Dizziness (2194)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

The device was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.There was no indication of a device malfunction from the available information.The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns all treatments must be administered under a physician''s prescription and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.Udi: (b)(4).

Event Description

A report was received on 24 oct 2023 from a 70 year old male patient with an extensive medical history including diabetes and end stage renal disease, who stated he went to hospital on an unspecified date to receive blood.Additional information was provided on 06 nov 2023 from the home therapy nurse (htn), stating both hemodialysis needles became dislodged during treatment and the patient lost an unspecified amount of blood on (b)(6) 2023.The patient felt dizzy, weak and fatigued, and went to the emergency department.While at the emergency department labs were drawn, patient''s hemoglobin was low (7.8g/dl), he was admitted to hospital and transfused with 2 units of packed red blood cells on (b)(6) 2023.The patient was discharged from the hospital in stable condition on (b)(6) 2023 and has since transitioned to in-center dialysis.

• 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: 18147344
• MDR Text Key: 328229126
• Report Number: 3003464075-2023-00100
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2023

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: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG