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

Model Number CAR-172-C

Device Problem Output Problem (3005)

Patient Problems Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Muscle Weakness (1967)

Event Date 03/14/2022

Event Type  Injury  

Event Description

A report was received on 20 apr 2022 from the home therapy nurse (htn) of a (b)(6) male with a medical history including end stage renal disease, who stated the patient experienced blood loss via an unclamped heparin line during hemodialysis therapy on (b)(6) 2022.Additional information was received on 05 may 2022 from the home therapy manager (htm) stating the patient lost approximately 650ml of blood during therapy and presented to the emergency department (ed) with fatigue, headache and generalized weakness where they were admitted on (b)(6) 2022.Treatment in the ed included administration of saline (175ml) and ondansetron (dose and route unspecified).The patient remained hospitalized until (b)(6) 2022 when he was released in stable condition.

Manufacturer Narrative

The involved cartridge was not received for evaluation.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.There was no indication of a device malfunction from the available information.The cartridge instructions for use provides information and warnings associated with performing hemodialysis therapy.It warns the user to secure caps and close clamps prior to use to prevent air entry or blood loss.

• 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: 14317677
• MDR Text Key: 291206803
• Report Number: 3003464075-2022-00016
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Public: +M535CAR172C0/$$052311177034+
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 11177034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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): Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 121 KG