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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500318N
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: on (b)(6) 2018, a user facility contacted fresenius after a patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a suspected dialyzer reaction on (b)(6) 2018. Subsequent attempts to obtain additional information have thus far proven unsuccessful. A temporal association exists between hd therapy utilizing the optiflux f180nr dialyzer, and the patient¿s adverse event(s) of hypersensitivity and/or allergic reaction. The documentation in this complaint file supports a probable association between the fresenius optiflux f180nr dialyzer, and the patient¿s adverse event(s). It was reported the patient experienced a hypersensitivity reaction to the optiflux f180nr dialyzer on (b)(6) 2018. While uncommon, hypersensitivity reactions are known to occur with use of optiflux dialyzers. Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.
 
Event Description
A user facility medical professional contacted the medinfo line and stated the patient was having a reaction to the optiflux 180nr dialyzer. Due diligence attempts were exhausted, but additional information was not provided.
 
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Brand NameOPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key8186671
MDR Text Key131189475
Report Number1713747-2018-00499
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0500318N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
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