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

Model Number CAR-172-C

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

Patient Problems Dizziness (2194); Blood Loss (2597)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

The cartridge was not received for evaluation.Log files were received and analyzed which showed treatment on the date of the event was unremarkable with no evidence of a product deficiency.Photos of the device were received and reviewed and no malfunction was identified.The photos show the that the cartridge heparin line was improperly clamped and lacked occlusion, indicating the blood loss likely occurred from this location.A review of the device history record (dhr) was conducted which confirmed the device met all quality criteria and manufacturing specifications prior to release.The nxstage system one user guide and car-172-c instructions for use (ifu) provide information and warnings for use of the device.The ifu warns to always visually inspect the package and product before use, and to not use any supplies after their expiration date.A trained and qualified person must observe all treatments, check the system for blood and fluid leaks during treatment and pay close attention to the bloodline and access connections.The documentation warns to make sure all manual connections are secure and fluid tight before starting treatment, and to secure caps and close clamps after priming and after each use.

Event Description

A report was received on (b)(6) 2020 from the home therapy nurse (htn) of a (b)(6) year old male with multiple comorbidities including end stage renal disease and a history of non-compliance with his treatment schedule, stating the patient was performing a home hemodialysis treatment while sleeping at night and experienced an unconfirmed amount of blood loss requiring hospitalization on (b)(6) 2020.Additional information was received on 04 jun 2020 from the htn stating the patient felt dizzy and was admitted to hospital on (b)(6) 2020 where he received one unit of blood.The patient was discharged on (b)(6) 2020 to continue therapy with the nxstage system.

• 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: 10223987
• MDR Text Key: 197406254
• Report Number: 3003464075-2020-00036
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$031970877022A
• Combination Product (y/n): Y
• 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: 01/01/2005,07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2019
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 70877022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 114