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

Model Number CAR-170-C

Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411)

Event Date 10/21/2021

Event Type  Injury  

Event Description

A report was received on 22 oct 2021 from the home therapy nurse (htn) of a (b)(6)-year-old female patient with a medical history including multiple comorbidities and end stage renal disease, who stated that the patient experienced decreased blood pressure (nos) during a hemodialysis treatment on (b)(6) 2021. Per the htn, the patient attempted a saline bolus and noted a blood leak from ¿a small pinhole leak in the art line¿. Emergency medical services (ems) were contacted and transported patient to hospital for evaluation. Additional information was received on 26 oct 2021 from the htn stating that the patient was admitted to hospital from (b)(6) 2021 for acute blood loss anemia and syncope. While admitted, patient received 2 units of red blood cells. Per the htn, the patient has recovered without sequelae and continues to treat with the nxstage system.

Manufacturer Narrative

The product was received for evaluation and successfully passed testing, no leaks or occlusions were observed and all luers and connectors were intact with no compromised integrity found. A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. Available log files were retrieved and analyzed which showed device performance was without deficiency and was unremarkable. 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.

• 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
• MDR Report Key: 12805635
• MDR Text Key: 280746899
• Report Number: 3003464075-2021-00066
• 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

• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 10777046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/12/2021 Patient Sequence Number: 1