MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500316E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 02/28/2024

Event Type  Injury  

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 160nre dialyzer, and the serious adverse events of a hypersensitivity/allergic reaction, characterized by pruritus, hives, heat, and rash.The definitive cause of the rash is unknown; therefore, causality cannot firmly be established.However, since the patient transitioned to a nipro dialyzer, followed by a baxter revaclear dialyzer, there has been no return of symptoms.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.Based on the information available, the optiflux 160nre dialyzer cannot be disassociated from the serious adverse events.While no manufacturing defect(s) was reported, the serious adverse events did occur after the patient completed her first hd treatment.Furthermore, given the patient¿s symptoms were indicative of a hypersensitivity/allergic reaction, the patient¿s favorable response to an alternative dialyzer (different sterilant), and no sample available for manufacturer evaluation, the optiflux 160nre dialyzer cannot be excluded from having a possible causal or contributory role in the serious adverse events.

Event Description

On 25/mar/2024, fresenius became aware via a medwatch 3500 form, this patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 160nre dialyzer for renal replacement therapy (rrt) reportedly experienced an allergic reaction on (b)(6) 2024.The medwatch form indicated the patient arrived at the outpatient hemodialysis clinic on (b)(6) 2024, and reported she experienced a rash on her chest, abdomen, and back on the evening of (b)(6) 2024, after her first hd treatment.The patient described the rash as ¿hot, itchy, and red with hives.¿ the patient did not seek medical attention, instead she took benadryl, ibuprofen (dosages not provided), and her daughter applied a tea compress over the entire rash.The patient stated her primary care physician (pcp) assessed the rash on (b)(6) 2024 and thought it resembled a contact dermatitis, however by that point the symptoms had subsided, and the patient felt better.The patient denied recently changing laundry detergent, medications, and/or using any new products (i.E., lotions, perfume).Additional follow-up obtained on (b)(6) 2024 revealed the nephrologist discontinued the patient¿s use of an optiflux 160nre dialyzer prior to hd therapy on (b)(6) 2024.The patient was transitioned to a nipro dialyzer, followed by a baxter revaclear dialyzer (current), both of which were utilized without signs/symptoms of a reaction.Although the definitive cause of the rash is unknown, since switching dialyzer types the rash has not returned.The patient has recovered from the serious adverse events.Per the patient¿s outpatient clinical manager (cm), there were no fresenius device(s) and/or product(s) defects, or quality issues noted.

Event Description

On 25/mar/2024, fresenius became aware via a medwatch 3500 form, this patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 160nre dialyzer for renal replacement therapy (rrt) reportedly experienced an allergic reaction on (b)(6) 2024.The medwatch form indicated the patient arrived at the outpatient hemodialysis clinic on (b)(6) 2024 and reported she experienced a rash on her chest, abdomen, and back on the evening of (b)(6) 2024 after her first hd treatment.The patient described the rash as ¿hot, itchy, and red with hives.¿ the patient did not seek medical attention, instead she took benadryl, ibuprofen (dosages not provided), and her daughter applied a tea compress over the entire rash.The patient stated her primary care physician (pcp) assessed the rash on (b)(6) 2024 and thought it resembled a contact dermatitis, however by that point the symptoms had subsided, and the patient felt better.The patient denied recently changing laundry detergent, medications, and/or using any new products (i.E., lotions, perfume).Additional follow-up obtained on 3/apr/2024 revealed the nephrologist discontinued the patient¿s use of an optiflux 160nre dialyzer prior to hd therapy on (b)(6) 2024.The patient was transitioned to a nipro dialyzer, followed by a baxter revaclear dialyzer (current), both of which were utilized without signs/symptoms of a reaction.Although the definitive cause of the rash is unknown, since switching dialyzer types the rash has not returned.The patient has recovered from the serious adverse events.Per the patient¿s outpatient clinical manager (cm), there were no fresenius device(s) and/or product(s) defects, or quality issues noted.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.During the lot history review it was noted that there was one other compliant reported against the lot.The complaint is not associated with the current event.The number of complaints for the assigned symptom code on the lot number was reviewed and it was determined that no lot complaint excursion occurred.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were multiple approved temporary deviation notices (dn) reported on the lot 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 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 160NRE DIALYZER FINISHED ASSY.
• Type of Device: 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: 19087012
• MDR Text Key: 339898689
• Report Number: 0001713747-2024-00292
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 0500316E
• Device Lot Number: 24AU06008
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 84 KG