MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX ADVANCED FRESENIUS POLYSULFONE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number F160NR

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2022

Event Type  malfunction  

Event Description

Dialyzer found to be leaking normal saline via the arterial connection.Connection was resecured and dried to assess any further leaking.Leaking was noted again and, upon inspection, a small amount of material found floating within the lateral port connected to the red hansen.Dialyzer was exchanged for new equipment.Fda safety report id# (b)(4).

• Brand Name: OPTIFLUX ADVANCED FRESENIUS POLYSULFONE DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA
• MDR Report Key: 14162157
• MDR Text Key: 289775576
• Report Number: MW5109192
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F160NR
• Device Lot Number: 22BU06022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1