MAUDE Adverse Event Report: FRESENIUS USA MANUFACTURING, INC. FRESENIUS 160NR OPTIFLUX DIALYZERS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 20LU06012

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2021

Event Type  No Answer Provided  

Event Description

While priming 3 dialyzers used for hemodialysis all with same lot number.Saline noticed to be leaking from venous end of header.It appears as there is not an adequate seal.This was caught all 3 times prior to placing patients on the machine.Fresenius 160nr optiflux dialyzers.Case removed from area by storeroom.However, all new cases have same lot number.Will need to be monitored as we use them.Unable to remove all due to no other 160nrs with different lot number.Lot number 20lu06012 exp date 9/3/2023.Fda safety report id #(b)(4).

• Brand Name: FRESENIUS 160NR OPTIFLUX DIALYZERS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA MANUFACTURING, INC.
• MDR Report Key: 11261265
• MDR Text Key: 230084723
• Report Number: MW5099120
• Device Sequence Number: 3
• Product Code: KDI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/28/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/03/2023
• Device Lot Number: 20LU06012
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1