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); Rash (2033); Loss of consciousness (2418); Swelling/ Edema (4577)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plant investigation: 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 optiflux 180nr dialyzer, and the serious adverse events of a dialyzer reaction (characterized by pruritus, hives, lip swelling, rigidity, and loss of consciousness), which required the early termination of treatment, the administration of supplemental oxygen, several rescue-based medications (including normal saline and solumedrol), and hospitalization.The definitive cause of the serious adverse events is unknown; therefore, causality cannot firmly be established.During hd therapy, blood comes into direct contact with a variety of materials and sterilization methods.Therefore, it is reasonable to conclude some patients may incur a hypersensitivity/allergic reaction while using these products.Additionally, hypersensitivity/allergic reactions have been known to occur days, months, or even years after use with the same dialyzer model.Based on the information available, the optiflux 180nr dialyzer cannot be disassociated from the serious adverse events.While no manufacturing defect or damage was reported, the serious adverse events did occur during hd therapy while utilizing the optiflux 180nr dialyzer.Furthermore, given the patient¿s symptoms were indicative of an allergic reaction, the lack of clinical follow-up, and no sample available for manufacturer evaluation, the optiflux 180nr dialyzer cannot be excluded from having a possible causal or contributory role in the serious adverse events.
Event or Problem Description
On 15/oct/2025, fresenius received a medwatch form 3500a regarding this patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 180nr dialyzer for renal replacement therapy (rrt) reportedly experienced a possible dialyzer reaction during hd therapy on (b)(6) 2025.Via the medwatch form 3500a, the patient arrived for his regularly scheduled outpatient hd treatment on (b)(6) 2025, and his pre-treatment vitals included: blood pressure = 135/65, pulse = 66, respirations = 18, temperature = 97.6.The treatment was initiated at 11:01 utilizing an optiflux 180nr dialyzer as prescribed.At approximately 14:41, the patient complained of itching (pruritus) and the treatment was terminated.The patient was provided supplemental oxygen (volume not provided), intravenous (iv) normal saline bolus (volume not provided), and oral benadryl 50 mg.The nurse practitioner evaluated the patient chairside and recommended the patient should go to the emergency room, however the patient declined.At approximately 14:51, the patient¿s condition had worsened and included hives (patient¿s trunk, extremities, neck) and lip swelling.An intramuscular (im) dose of solu-medrol was administered, and emergency medical services (ems) were contacted.While being transported to the hospital, the patient became rigid and lost consciousness.No additional details were obtained during follow-up, however the patient was discharged home and returned to the outpatient dialysis clinic for his next scheduled treatment on (b)(6) 2025.Subsequent attempts to obtain additional clinical information (e.G., confirmed cause, alternate dialyzer type, any return of symptoms) were unsuccessful.
Event or Problem Description
On 15/oct/2025, fresenius received a medwatch form 3500a regarding this patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 180nr dialyzer for renal replacement therapy (rrt) reportedly experienced a possible dialyzer reaction during hd therapy on (b)(6) 2025.Via the medwatch form 3500a, the patient arrived for his regularly scheduled outpatient hd treatment on (b)(6) 2025, and his pre-treatment vitals included: blood pressure = 135/65, pulse = 66, respirations = 18, temperature = 97.6.The treatment was initiated at 11:01 utilizing an optiflux 180nr dialyzer as prescribed.At approximately 14:41, the patient complained of itching (pruritus) and the treatment was terminated.The patient was provided supplemental oxygen (volume not provided), intravenous (iv) normal saline bolus (volume not provided), and oral benadryl 50 mg.The nurse practitioner evaluated the patient chairside and recommended the patient should go to the emergency room, however the patient declined.At approximately 14:51, the patient¿s condition had worsened and included hives (patient¿s trunk, extremities, neck) and lip swelling.An intramuscular (im) dose of solu-medrol was administered, and emergency medical services (ems) were contacted.While being transported to the hospital, the patient became rigid and lost consciousness.No additional details were obtained during follow-up, however the patient was discharged home and returned to the outpatient dialysis clinic for his next scheduled treatment on (b)(6) 2025.Subsequent attempts to obtain additional clinical information (e.G., confirmed cause, alternate dialyzer type, any return of symptoms) were unsuccessful.
Additional 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.

• 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: 23395632
• Report Number: 0001713747-2025-00833
• Device Sequence Number: 13265669
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/02/2026
• 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 BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 84 KG