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

Model Number CAR-172-C

Device Problems Device Difficult to Setup or Prepare (1487); Improper Flow or Infusion (2954); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194); Hypovolemia (2243)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

There was no device malfunction.The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly and the instructions for use states "check the system for blood and fluid leaks during treatment, and pay close attention to the blood line and access connections." a device history record (dhr) review was conducted for the reported lot number and revealed the product was released for distribution having met quality and manufacturing specifications and requirements.

Event Description

A report was received on 20 dec 2022 regarding a 60 year old female patient with a medical history including end stage renal disease, stating she experienced an unspecified blood loss during a home hemodialysis treatment on (b)(6) 2022.The patient was transported to the emergency department and received a blood transfusion.Additional information was received on 21 dec 2022 from the home therapy nurse (htn) who stated the patient felt "woozy" and was hypotensive as a result of the blood loss, symptoms resolved upon receiving the transfusion.Per the htn, the blood loss was from the heparin line which had not been properly clamped.The patient has recovered without sequelae and continues to treat with the nxstage system.

• 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: 16130726
• MDR Text Key: 307013484
• Report Number: 3003464075-2023-00003
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Public: +M535CAR172C0/$$022420977010+
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140526
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2024
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 20977010
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• 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: 60 YR
• Patient Sex: Female