MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number NX1000-5-A

Device Problem Gas/Air Leak (2946)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 04/04/2020

Event Type  Death  

Event Description

Patient status post aortic valve replacement, 5 vessel cabg and atrial flutter ablation.Approximately 26 hours into crrt, patient's blood pressure dropped.Physician and nursing at the bedside and noticed what they believed to be air in the access line of the crrt tubing.Venous and access lines clamped immediately.Machine stopped.Loss of pulse, code blue initiated.Code team and cardiothoracic surgeon unable to achieve rosc (return of spontaneous circulation).Patient pronounced.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 10008789
• MDR Text Key: 189329192
• Report Number: 10008789
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NX1000-5-A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 28470 DA