MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F180NR HF 12/CS 1.7SA ETO; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500318N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via voluntary medwatch that a hemodialysis (hd) patient experienced a dialyzer reaction during treatment while utilizing the optiflux f180nr dialyzer.The patient¿s treatment was initiated on (b)(6) 2025 at 0611 local time.The patient¿s pre-treatment vital signs were blood pressure (bp) 157/115, pulse (p) 96, respirations (r) 18, and temperature (t) 96.7.The treatment was started utilizing a fresenius 2008t machine, optiflux f180nr dialyzer, combiset bloodlines, normal saline, dialysate of granuflo 2.0k, 2.5ca, 1.0mg, 100 dextrose, and naturalyte bicarb.At 0848 the patient reported itching.The patient was administered benadryl 50mg intravenous push (ivp).Treatment was continued.The patient verbalized relief from the itching at approximately 0900.Treatment was completed at 1000.The patient¿s post-treatment vitals were bp 110/62, p 83, r18, and t 96.6.The patient was discharged home alert and oriented.The optiflux 180nr was added as an allergy.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.
Additional 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 possible causal relationship between the fresenius optiflux f180nr dialyzer and the patient¿s reaction (characterized by itching) with the administration of benadryl as the reaction was reported to have occurred during treatment.Although rare, hypersensitivity or anaphylactoid reactions to dialyzers are a known risk during hemodialysis.The exposure of the patient¿s blood to a foreign substance present in the extracorporeal circuit is the result of an immunoallergic response.There is no evidence of an optiflux f180nr dialyzer product deficiency or malfunction, but rather a possible bio-incompatibility between the patient and the membrane material.However, although there is no allegation or evidence of a product malfunction or deficiency, the optiflux f180nr dialyzer cannot be excluded as causing or contributing to the patient¿s adverse event.
Event or Problem Description
It was reported via voluntary medwatch that a hemodialysis (hd) patient experienced a dialyzer reaction during treatment while utilizing the optiflux f180nr dialyzer.The patient¿s treatment was initiated on (b)(6) 2025, at 0611 local time.The patient¿s pre-treatment vital signs were blood pressure (bp) 157/115, pulse (p) 96, respirations (r) 18, and temperature (t) 96.7.The treatment was started utilizing a fresenius 2008t machine, optiflux f180nr dialyzer, combiset bloodlines, normal saline, dialysate of granuflo 2.0k, 2.5ca, 1.0mg, 100 dextrose, and naturalyte bicarb.At 0848 the patient reported itching.The patient was administered benadryl 50mg intravenous push (ivp).Treatment was continued.The patient verbalized relief from the itching at approximately 0900.Treatment was completed at 1000.The patient¿s post-treatment vitals were bp 110/62, p 83, r18, and t 96.6.The patient was discharged home alert and oriented.The optiflux 180nr was added as an allergy.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.
Additional 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.One lot was found to have been delivered in this time period.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 one non-conformance (nc) in the production of this lot which was unrelated to the reported complaint event.There was no indication of product nonacceptance, deviation, nc, 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.

• Brand Name: OPTIFLUX F180NR HF 12/CS 1.7SA ETO
• Common Device Name: 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
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 23677151
• Report Number: 0001713747-2025-00982
• Device Sequence Number: 21440257
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K002277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0500318N
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 11/30/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; GRANUFLO 2.0K 2.5CA 1.0MG 100 DEXTROSE; GRANUFLO 2.0K 2.5CA 1.0MG 100 DEXTROSE; NATURALYTE BICARBONATE; NATURALYTE BICARBONATE; NORMAL SALINE; NORMAL SALINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White