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

Model Number CAR-500

Device Problem Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/19/2021

Event Type  Injury  

Manufacturer Narrative

User facility report #: (b)(4).The cartridge was discarded and not available for evaluation.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.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.

Event Description

A report was received on (b)(6) 2021 from the risk manager of a critical care facility regarding a (b)(6) male patient, who stated that a therapy fluid leak was present during a continuous veno-venous hemofiltration (cvvh) treatment on (b)(6) 2021.The patient¿s blood was unable to be returned and the patient was given a transfusion of unit of packed red blood cells.Although requested, additional information has not been 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
• MDR Report Key: 12341276
• MDR Text Key: 267227026
• Report Number: 3003464075-2021-00038
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$112210378002H
• Combination Product (y/n): Y
• 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,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 10378002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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
• Patient Age: 51 YR
• Patient Weight: 37