MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY; 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	01/01/2023
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 180nre dialyzer, and the serious adverse event(s) of a hypersensitivity/allergic reaction, characterized by pruritis.The patient¿s pruritis occurred during hd therapy (unknown if medical intervention was provided/required) and was reportedly remediated by the utilization of an alternative dialyzer (nipro cellentia - alternative sterilant).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 reactions have been known to occur days, months, or even years after use with the same dialyzer model.It should be noted that limited follow-up information precluded a more comprehensive investigation.However, based on the information available, the optiflux 180nre dialyzer cannot be disassociated from the serious adverse event(s).While there was no report that a manufacturing defect was noted/observed, the patients did experience pruritis during treatment, which is considered a traditional sign/symptom of a hypersensitivity/allergic reaction.Furthermore, given the patient¿s favorable response to the alternate dialyzer, and no sample available for manufacturer investigation/evaluation, the optiflux 180nre dialyzer cannot be excluded from having a causal and/or contributory role in the serious adverse events.
Event or Problem Description
On (b)(6) 2023, fresenius became aware a patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 180nre dialyzer for renal replacement therapy (rrt) reportedly experienced allergic reactions, which caused itching (pruritis).No additional information was provided during intake.Follow-up with the clinical manager (cm) revealed there was a patient experiencing pruritus during hd therapy.Additional information (patient demographics, hd orders, medication records, hospital records) was requested via email, however no response has been received.Despite the lack of detailed follow-up, the cm reported the patient is now undergoing hd therapy utilizing a nipro cellentia dialyzer without further incident.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A lot history review was performed.There were two other complaints reported against the lot.The complaints addressed a patient reaction and are mentioned above (no samples).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 or Problem Description
On (b)(6) 2023, fresenius became aware a patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 180nre dialyzer for renal replacement therapy (rrt) reportedly experienced allergic reactions, which caused itching (pruritis).No additional information was provided during intake.Follow-up with the clinical manager (cm) revealed there were a patient experienced pruritus during hd therapy.Additional information (patient demographics, hd orders, medication records, hospital records) was requested via email, however no response has been received.Despite the lack of detailed follow-up, the cm reported the patient is now undergoing hd therapy utilizing a nipro cellentia dialyzer without further incident.
Event or Problem Description
On 11/aug/2023, fresenius became aware a patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 180nre dialyzer for renal replacement therapy (rrt) reportedly experienced allergic reactions, which caused itching (pruritis).No additional information was provided during intake.Follow-up with the clinical manager (cm) revealed there were a patient experienced pruritus during hd therapy.Additional information (patient demographics, hd orders, medication records, hospital records) was requested via email, however no response has been received.Despite the lack of detailed follow-up, the cm reported the patient is now undergoing hd therapy utilizing a nipro cellentia dialyzer without further incident.
Additional Manufacturer Narrative
Correction.
Event or Problem Description
On 11/aug/2023, fresenius became aware a patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 180nre dialyzer for renal replacement therapy (rrt) reportedly experienced allergic reactions, which caused itching (pruritis).No additional information was provided during intake.Follow-up with the clinical manager (cm) revealed there were a patient experienced pruritus during hd therapy.Additional information (patient demographics, hd orders, medication records, hospital records) was requested via email, however no response has been received.Despite the lack of detailed follow-up, the cm reported the patient is now undergoing hd therapy utilizing a nipro cellentia dialyzer without further incident.

• Brand Name: OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
• 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: 17648085
• Report Number: 0001713747-2023-00588
• Device Sequence Number: 7269127
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/01/2023

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 0500318N
• Device Lot Number: 23BU04024
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 09/22/2023; 11/01/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/19/2023; 09/26/2023; 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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 BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown