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

Model Number NX1000-3

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194); Loss of consciousness (2418)

Event Date 08/27/2023

Event Type  Injury  

Event Description

A report was received on 31 aug 2023 from a 53 year old male patient with a medical history including diabetes and end stage renal disease, who stated an unspecified amount of blood loss occurred due to an inadvertently unclamped bloodline during a home hemodialysis treatment without the caregiver present on (b)(6) 2023.Per the patient, he felt dizzy, passed out and subsequently received a unit of blood.Additional information was received on 01 sep 2023 from the home therapy nurse (htn), who stated the patient had his hemoglobin tested after the event and was sent to outpatient infusion services for a transfusion.The patient has since recovered without sequelae and resumed therapy with the nxstage system.

Manufacturer Narrative

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).

• 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: 17739104
• MDR Text Key: 323317820
• Report Number: 3003464075-2023-00070
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2023

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: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 106 KG