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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
Model Number 0500316E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd therapy utilizing the fresenius optiflux 160nre dialyzer, and the serious adverse events of pain and chronic rash (exacerbated by hd therapy).The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.However, follow-up with the cm revealed the patient had a favorable response to an alternative dialyzer (nipro cellentia 17h), with a substitute mode of sterilization.The cm reported the patient underwent hd without a return or worsening of the patient¿s rash or pain.Limited information precluded a more comprehensive investigation.Based on the totality of the information available, the fresenius optiflux 160nre dialyzer cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events.While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit.Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.
 
Event Description
It was reported to fresenius that a patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was experiencing a chronic rash, which worsened while undergoing hd therapy utilizing an optiflux 160nre dialyzer (specifics not provided).Follow-up with the outpatient clinical manager (cm) revealed a substitute dialyzer (nipro cellentia 17h) was utilized on (b)(6) 2021 with favorable results.The patient reportedly completed treatment without any complaints of pain or rash.Subsequent attempts to obtain additional information (e.G., patient demographics, treatment records, medical records, current disposition) have thus far proven unsuccessful.
 
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, a 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.The search yielded no results and the search parameters were expanded to find the last delivered lot with the reported catalog number.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.
 
Event Description
It was reported to fresenius that a patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was experiencing a chronic rash, which worsened while undergoing hd therapy utilizing an optiflux 160nre dialyzer (specifics not provided).Follow-up with the outpatient clinical manager (cm) revealed a substitute dialyzer (nipro cellentia 17h) was utilized on (b)(6) 2021 with favorable results.The patient reportedly completed treatment without any complaints of pain or rash.Subsequent attempts to obtain additional information (e.G., patient demographics, treatment records, medical records, current disposition) have thus far proven unsuccessful.
 
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Brand Name
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
MDR Report Key12164910
MDR Text Key261467584
Report Number1713747-2021-00216
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100149
UDI-Public00840861100149
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
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0500316E
Device Catalogue Number0500316E
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/14/2021
Supplement Dates Manufacturer Received07/22/2021
Supplement Dates FDA Received07/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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