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

Lot Number 01278003

Device Problems Fluid/Blood Leak (1250); Moisture Damage (1405)

Patient Problem Insufficient Information (4580)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

Nxstage cartridge lot #: 01278003 began leaking fluid out of bottom of cartridge while in machine, and connected to patient after priming appropriately.This caused a delay in care due to the machine being wet and not functioning properly, and having to wait for a new machine.This could have caused harm to patient if blood was lost or air sucked in to circuit.

• 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: 11444395
• MDR Text Key: 238629366
• Report Number: 11444395
• 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: 02/19/2021

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: 01278003
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA