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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
Catalog Number 0500318E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem 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.  .
 
Event Description
It was reported that a patient had a reaction to a fresenius dialyzer during hemodialysis (hd) treatment. Additional patient, event, and treatment information was requested, but was not provided.
 
Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation. As no lot number was provided for this complaint, an sap search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date. One lot found to have been delivered in this time period. A production records review was performed on the reported lots. 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 lots 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.
 
Manufacturer Narrative
Clinical investigation: based on the available information, there is a possible causal association between the fresenius optiflux 180nre dialyzer and the patient¿s reported allergic reaction (unknown signs and symptoms). Currently, there is no evidence of a dialyzer product deficiency or malfunction associated with the event. It is well-documented that patients on hemodialysis may experience hypersensitivity and allergic reactions due to the dialyzer membrane of various types of dialyzers. The fresenius optiflux 180nre dialyzer instructions for use cautions user of the known risk of hypersensitivity or anaphylactoid reactions to optiflux dialyzers during use. Should additional information become available, please resubmit for a clinical review and the clinical investigation will be updated accordingly.
 
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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
MDR Report Key8199948
MDR Text Key131515872
Report Number1713747-2018-00504
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 health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0500318E
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1
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