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

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

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

Event Date 05/29/2022

Event Type  malfunction  

Event Description

Cvvh filter had defective tubing.Shortly after the rn began the priming process, a puddle of normal saline was noticed beneath the cvvh machine.Rn noted a warped, open section of tubing where the leak originated from.The filter was removed and was never connected to the patient.

• Brand Name: NXSTAGE
• 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: 15852679
• MDR Text Key: 304205920
• Report Number: 15852679
• 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: 09/29/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1