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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.
 
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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
director, site quality
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 Key12164910
MDR Text Key261467584
Report Number1713747-2021-00216
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0500316E
Device Catalogue Number0500316E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/22/2021
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: 07/14/2021 Patient Sequence Number: 1
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