MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	0500318N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Additional 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 180nr dialyzer, and the serious adverse event of pruritus.Although the treatment record from (b)(6) 2022 was unavailable, medical records indicated the patient was actively undergoing hd therapy when the event occurred.The patient was provided iv benadryl, which was effective in reliving the pruritus.Based on the patient¿s response to the antihistamine, it is reasonable to discern a hypersensitivity reaction likely occurred.Based on the totality of the information available, the fresenius optiflux 180nr 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 or Problem Description
It was reported to fresenius that a hemodialysis (hd) patient experienced pruritus (wrist) during hd therapy on (b)(6) 2022.While hospitalized, the patient underwent hd therapy (heparin free), with complaints of wrist itching, and was given intravenous (iv) benadryl (dose not provided).The patient underwent hd again on friday (b)(6) 2022 (with heparin, no benadryl) without issue and was discharged home.
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.Three lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one to multiple approved temporary deviation notices (dn) reported on the lots which were unrelated to the complaint event.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 lots met all release criteria.The optiflux dialyzer instruction for use (ifu) indicates the following: ¿in rare cases, hypersensitivity reactions may occur during hemodialysis treatment.A history of allergies is an indication for careful monitoring of hypersensitivity reactions.¿ 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
It was reported to fresenius that a hemodialysis (hd) patient experienced pruritus (wrist) during hd therapy on (b)(6) 2022.While hospitalized, the patient underwent hd therapy (heparin free), with complaints of wrist itching, and was given intravenous (iv) benadryl (dose not provided).The patient underwent hd again on friday (b)(6) 2022 (with heparin, no benadryl) without issue and was discharged home.

• 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: 14215034
• Report Number: 0001713747-2022-00144
• Device Sequence Number: 4137526
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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 Model Number: 0500318N
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 132 KG