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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500316E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Reaction (2414)
Event Date 12/14/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: based on the available information, there is a likely causal association between the fresenius optiflux160nre dialyzer and the patient¿s allergic reaction (characterized by hives and itching 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 160 nre dialyzer product deficiency or malfunction. Should additional information become available, the clinical investigation will be updated accordingly.
 
Event Description
A user facility clinical manager reported that a patient experienced hives and mild itching during dialysis treatment using a fresenius f160 series dialyzer. The cause of the hives and itching was determined to be the patient¿s dialyzer type. The patient¿s nephrologist changed the dialyzer prescription to the fresenius f180 series, and the patient has completed subsequent dialysis treatments without further incident. There was no serious injury to the patient due to the reported event and the patient completed all of their dialysis treatments successfully. Additional event and prescription change information was requested, but was not available.
 
Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation. A production records review was performed on the reported lot. An investigation of the device history records (dhr) was conducted by the manufacturer. There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event. The lot met all release criteria. A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device. Therefore, the complaint is not confirmed.
 
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Brand NameOPTIFLUX 160NRE 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
MDR Report Key8203931
MDR Text Key131705160
Report Number1713747-2018-00507
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number0500316E
Device Lot Number18LU06018
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received02/12/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
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