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U.S. Department of Health and Human Services

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

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Swelling (2091); Reaction (2414)
Event Date 09/12/2019
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: based on the available information, there is a temporal and a likely causal relationship between the fresenius optiflux 180nre dialyzer and the patient¿s reaction (characterized by tongue swelling, shortness of breath and difficulty talking during the hd treatment). Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis. There is no evidence of an optiflux 180nre dialyzer product deficiency or malfunction. Additionally, although the patient experienced an adverse reaction during treatment, there is no allegation of a product malfunction or deficiency related to this event.
 
Event Description
A user facility clinical manager reported a hemodialysis (hd) patient attended regularly scheduled dialysis treatment. Pre vs 118/78, pulse 106, temp 99. 1. At approximately 10:34 dialysis initiated via a left upper arm avf. Within approximately 20 minutes, the patient stated that the tongue was swelling. The patient also had shortness of breath and difficulty speaking. Oxygen was provided, 911 called, and dialysis was terminated. Blood pressure 103/64, pulse 104. The patient was transported to the emergency room and later released. The patient recovered. Upon follow up, the clinical manager stated the patient did not experience any reaction until the treatment on (b)(6) 2019 with use of the optiflux 180nre dialyzer (the same dialyzer used for all previous treatments). The patient did not require hospital admission and was in the emergency room (er) for less than 24 hours prior to being discharged. The treatment received in the er is unknown. The patient continued hd treatment afterwards.
 
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Brand NameOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
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
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key9140423
MDR Text Key167018669
Report Number1713747-2019-00308
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Device Catalogue Number0500318E
Device Lot Number19HU03017
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 Received10/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2019
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: 10/01/2019 Patient Sequence Number: 1
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