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

Model Number NX1000-16-A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Shock (2072); Loss of consciousness (2418)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

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 provide information and warnings for use of the device.The user guide warns that treatment with the nxstage system one should only be done under the responsibility of a physician and performed by a trained and qualified person.A trained and qualified person must observe all treatments, check the system for blood leaks, pay close attention to the bloodlines and access during treatment and respond promptly and appropriately to all alarms and harmful conditions during treatment.(b)(4).

Event Description

A report was received on (b)(6) 2021 from a (b)(6) patient with a medical history of multiple comorbidities and end stage renal disease, stating the patient experienced bleeding near the access site approximately 8 minutes into a hemodialysis treatment on (b)(6) 2021 and emergency medical services (ems) were called.Additional information was received on 23 apr 2021 from the home therapy nurse (htn) stating that ems estimated a 2-liter blood loss at the scene.The patient was unresponsive and transported to the emergency department (ed), arriving in cardiac arrest due to hemorrhagic shock.In the ed, the patient was intubated and sedated.Resuscitation was performed successfully and included the facility¿s ¿massive transfusion protocol¿, achieving a return of spontaneous circulation (rosc).The patient stabilized, vascular surgery evaluated the patient¿s fistula and placed 2 sutures to achieve hemostasis.

• 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: nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 11757423
• MDR Text Key: 248404141
• Report Number: 3003464075-2021-00020
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170469
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2021

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: Lay User/Patient
• Device Model Number: NX1000-16-A
• Device Catalogue Number: CYCLER VERSIHD 1.0,NO NIBP MOD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 138