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

Lot Number 01078002

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

Bedside rn states that 3 different filters were malfunctioning and pulling air in during priming - all have same lot number.She saved the final one for this writer.Multiple recent events have occurred with nxstage cvvh filters not functioning correctly.In this case, no harm to patient as this issue was identified during priming before circuit was connected to patient.However, it did cause a delay in restarting cvvh for this pt due to the number of attempts to prime before one was successfully found that functioned correctly.

• Brand Name: NXSTAGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 11588570
• MDR Text Key: 242917200
• Report Number: 11588570
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 01078002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA