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

Model Number CAR-172-C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Blood Loss (2597); Syncope/Fainting (4411)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

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.The nxstage system one user guide and car-172-c instructions for use provide information and warnings for use of the device.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 02 oct 2020 from a home therapy nurse (htn) regarding a (b)(6) year old female with multiple comorbidities including end stage renal disease, who experienced an adverse event when blood leaked from the cartridge while performing a home hemodialysis treatment without a care partner present on (b)(6) 2020.Additional information was received 02-09 oct 2020 from the htn stating the patient was found unresponsive with an approximate 300ml blood loss from the unclamped heparin line and emergency medical services (ems) were summoned.Upon arrival of ems the patient had regained consciousness and was hypotensive (nos) followed by a syncopal episode on standing.She was transported to the emergency room and received a 1 unit blood transfusion with improvement in blood pressure and an increase in hemoglobin from 8.7g/dl to 9.2g/dl.She was discharged same day in stable condition.

• 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: 10739601
• MDR Text Key: 213247260
• Report Number: 3003464075-2020-00073
• Device Sequence Number: 1
• Product Code: KDI
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 00777012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 64