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

Model Number CAR-124-C

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Hemolysis (1886)

Event Date 10/13/2023

Event Type  Injury  

Event Description

A report was received on 03 nov 2023 from the health professional (hp) of a female patient with a medical history including end stage renal disease, who stated the patient experienced signs and symptoms of hemolysis including abdominal pain and feeling unwell with a decrease in hemoglobin (nos) during a hemodialysis treatment on 13 oct 2023.Additional information was received on 07 nov 2023 from the hp who stated the patient was hospitalized to receive blood (nos) and pain management.Per the hp, the symptoms were related to dialysis tubing that likely became kinked during therapy.The patient recovered without sequelae and was discharged after three days.

Manufacturer Narrative

The product was not returned for evaluation.A review of the device history record was performed confirmed the device was released for distribution having met quality and manufacturing specifications and requirements.Per the nurse, the event was likely caused by the tubing inadvertently becoming kinked during 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: 18159030
• MDR Text Key: 328390420
• Report Number: 3003464075-2023-00101
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2023

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: Health Professional
• Device Model Number: CAR-124-C
• Device Catalogue Number: CAR-124-C
• Device Lot Number: 30277047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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; Hospitalization
• Patient Sex: Female
• Patient Weight: 60 KG