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

Model Number NX1000-5-A

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Respiratory Arrest (4461)

Event Date 08/29/2021

Event Type  Injury  

Manufacturer Narrative

The involved device was not received 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.Available log files were retrieved and analyzed which showed the device alarmed as designed to alert the operator to take action.Per the user guide, the operator is instructed to end the treatment and not rinse back the blood if there is indication of clotting present.Udi: (b)(4).

Event Description

A report was received on 30 aug 2021 from the cardiovascular intensive care unit (cvicu) nurse of a critical care patient with unspecified pathology and receiving multiple concurrent vasopressors (nos), stating that the patient "coded" during rinseback of a renal replacement session on (b)(6) 2021.Additional information was received on 14 sep 2021 from the cvicu nurse stating that the patient had a history of clotting each day over the previous 6 days of renal replacement therapy (anticoagulant details not provided) with multiple associated high-pressure alarms.The nurse elected to flush the dialyzer for possible clotting and return the patient's blood.Per the nurse, "as soon as the return of blood started, the sa02 decreased & bp decreased." additional information was requested and not provided.

• 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: 12513527
• MDR Text Key: 272736492
• Report Number: 3003464075-2021-00043
• Device Sequence Number: 1
• Product Code: KDI
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NX1000-5-A
• Device Catalogue Number: ACUTE CYCLER 3RD EDITION, ROHS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• 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): Required Intervention