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

Model Number CAR-172-C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Headache (1880); Hearing Impairment (1881); Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Blurred Vision (2137); Dizziness (2194)

Event Date 11/05/2022

Event Type  Injury  

Event Description

A report was received on 21 nov 2022 from the clinical manager (cm) of a 47-year-old female patient with a medical history including multiple comorbidities and end stage renal disease, who stated the patient experienced a blood leak during a home hemodialysis treatment on (b)(6) 2022.Per the cm, there was an estimated blood loss of 400 ml and the patient experienced decreased blood pressure (nos), weakness, lightheadedness, dizziness, headache, blurry vision, and decreased hearing.Emergency medical services were contacted, the patient was stabilized, transported to hospital and admitted on (b)(6) 2022.Additional information was received on 23 nov 2022 from the cm stating that the patient recovered without sequelae, was discharged on (b)(6) 2022 and continues to treat with the nxstage system.

Manufacturer Narrative

The cartridge was discarded and not available for evaluation.The reporter confirmed the clamp was incorrectly closed and was not properly occluding the bloodline during treatment.All product is released for distribution having met quality and manufacturing specifications and requirements.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".

• 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: 15900211
• MDR Text Key: 304688373
• Report Number: 3003464075-2022-00079
• Device Sequence Number: 1
• Product Code: KDI
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2022

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: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 82 KG