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

Model Number CAR-505

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/29/2023

Event Type  malfunction  

Event Description

A report was received on (b)(6) 2023 from the nurse of a 58-year-old critical care patient with unspecified pathology, who stated the dialysis tubing broke and the patient sustained a blood loss during continuous renal replacement therapy (crrt) on (b)(6) 2023.Per the nurse, normal saline was running concurrently at 500ml/hour through the dialysis circuit.Additional information was received on (b)(6) 2023 from the intensive care unit nurse manager (nm) stating that the patient did not experience any symptoms or require additional medical intervention and resumed crrt with a new dialysis circuit using the nxstage system.

Manufacturer Narrative

The cartridge was not received for evaluation.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.The instructions for use includes warnings about concurrent use of fluid delivery devices and warns the user to check for blood and fluid leaks during treatment with close attention to the blood line and 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: 16352025
• MDR Text Key: 309474326
• Report Number: 3003464075-2023-00017
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR5050
• UDI-Public: +M535CAR5050/$$072320178044X
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133547
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Device Lot Number: 20178044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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): Other
• Patient Age: 58 YR