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U.S. Department of Health and Human Services

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

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FRESENIUS USA MANUFACTURING, INC. FRESENIUS 160NR OPTIFLUX DIALYZERS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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).
 
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Brand NameFRESENIUS 160NR OPTIFLUX DIALYZERS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS USA MANUFACTURING, INC.
MDR Report Key11261265
MDR Text Key230084723
Report NumberMW5099120
Device Sequence Number1
Product Code KDI
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number20LU06012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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