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

Model Number NX1000-3-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Fatigue (1849); Dizziness (2194); Anxiety (2328); Pallor (2468)

Event Date 01/04/2024

Event Type  Injury  

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.Based on the available information, there is no indication that a malfunction occurred.All treatments must be administered under a physician''s prescription and performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician so that alarms and harmful conditions can be responded to promptly.Udi: (b)(4).

Event Description

A report was received on 15 jan 2024 from the caregiver of a 62 year old female patient with multiple cardiovascular comorbidities, end stage renal disease and a history of non-compliance with scheduled hemodialysis treatments, who stated treatment was terminated without rinseback when the cycler ¿went blank¿ and alarmed (nos) during treatment on (b)(6) 2024.The caregiver stated the patient experienced pallor, weakness, anxiety, and dizziness following hemodialysis treatment and was subsequently admitted to hospital with ''fluid build up in her lungs'' on (b)(6) 2024.Additional information was received on 19 jan 2024 from the healthcare professional (hcp) who stated the patient is consistently non-compliant with hemodialysis treatments and was hospitalized with dyspnea, anemia (hemoglobin of 10.2g/dl), lower respiratory tract infection, and bilateral pleural effusion.Treatment in hospital included unspecified ¿transfusions¿, ¿antibiotics¿ and chest drainage.The date of hospital discharge was not provided.

• 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: 18646194
• MDR Text Key: 334618324
• Report Number: 3003464075-2024-00014
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2024

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-A
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER, ROHS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 103 KG