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

Catalog Number 0500318E

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Anxiety (2328)

Event Date 03/27/2024

Event Type  Injury  

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 optiflux 180nre dialyzer, and the serious adverse events of a hypersensitivity/allergic reaction, characterized by feelings of throat closure, dyspnea, anxiety, and hypotension.The definitive cause of the serious adverse events is unknown; therefore, causality cannot firmly be established.However, since the patient transitioned to a nipro cellentia h 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 180nre dialyzer cannot be disassociated from the serious adverse events.While no manufacturing defects were reported, the serious adverse events did occur while the patient was undergoing hd therapy utilizing the optiflux 180nre dialyzer.Furthermore, given the patient¿s symptoms were indicative of a hypersensitivity/allergic reaction (successfully treated with benadryl), the patient¿s favorable response to an alternative dialyzer (different sterilant), and no sample available for manufacturer evaluation, the optiflux 180nre dialyzer cannot be excluded from having a probable causal or contributory role in the serious adverse events.

Event Description

It was reported to fresenius that a hemodialysis (hd) patient experienced an allergic reaction during hd therapy while utilizing an optiflux 180nre dialyzer.The patient was undergoing hd therapy when they became short of breath (dyspnea), anxious, hypotensive, and the feeling as though their throat was closing.The patient was reportedly treated with benadryl (dosage, route, frequency, duration not provided) and their symptoms improved.Following the serious adverse events, the patient¿s treatment was terminated early (timeline not provided), and they were sent home for the day.A registered nurse (rn) from the patient¿s outpatient hd center reported the patient has experienced similar reactions while utilizing the baxter revaclear dialyzer.However, while using a nipro cellentia h dialyzer there has been no return of symptoms.The optiflux 180nre dialyzer that was in use when the reaction occurred was not available to be sent back for evaluation.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As a lot number was not provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to this dialysis facility in the three months prior to the complaint occurrence date.There were no dialyzers with the reported catalog number delivered during this time frame.The search was then extended to find the last delivered lot with the reported catalog number.The search did not yield any results.Therefore, a production records review was not performed, and the device history records (dhr) could not be investigated.Based on the information available, a definitive conclusion regarding the complaint incident cannot be reached.

Event Description

It was reported to fresenius that a hemodialysis (hd) patient experienced an allergic reaction during hd therapy while utilizing an optiflux 180nre dialyzer.The patient was undergoing hd therapy when they became short of breath (dyspnea), anxious, hypotensive, and the feeling as though their throat was closing.The patient was reportedly treated with benadryl (dosage, route, frequency, duration not provided) and their symptoms improved.Following the serious adverse events, the patient¿s treatment was terminated early (timeline not provided), and they were sent home for the day.A registered nurse (rn) from the patient¿s outpatient hd center reported the patient has experienced similar reactions while utilizing the baxter revaclear dialyzer.However, while using a nipro cellentia h dialyzer there has been no return of symptoms.The optiflux 180nre dialyzer that was in use when the reaction occurred was not available to be sent back for evaluation.

• Brand Name: OPTIFLUX 180NRE 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: 19140256
• MDR Text Key: 340562155
• Report Number: 0001713747-2024-00317
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: 0500318E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male