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

Model Number CAR-500

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

Patient Problems Hemorrhage/Bleeding (1888); Shock (2072); Peritonitis (2252)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

The cartridge was discarded and was 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 30 jun 2021 from the risk manager (rm) of a (b)(6) male critical care patient admitted to the intensive care unit (icu) for acute on chronic kidney failure, spontaneous bacterial peritonitis and shock, stating that continuous renal replacement therapy (crrt) was terminated without rinseback after troubleshooting system alarms, and the patient experienced an estimated blood loss of 310ml on (b)(6) 2021.The patient received a blood transfusion (nos) secondary to a low hematocrit (value not provided) level later in the day on (b)(6) 2021.Additional information was received on 30 jun 2021 from the rm stating that the patient recovered to baseline status of admission to the icu and was able to resume crrt with new cartridge on (b)(6) 2021.

• 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: 12100740
• MDR Text Key: 259589676
• Report Number: 3003464075-2021-00032
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$042201078004I
• 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: 07/01/2021

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: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 01078004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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: 70 YR