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

Model Number 0500316E

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

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Reaction (2414)

Event Date 01/01/2020

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 fresenius optiflux 160nre dialyzer and the serious adverse events of dialyzer reaction, characterized by hypertension and headache, which required a change in dialyzer type (baxter revaclear, not a fresenius product).The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.However, given the patient¿s favorable response to the baxter revaclear dialyzer, a possible causal or contributory role cannot be excluded.Based on the information available, the optiflux 160nre dialyzer cannot be disassociated from the 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 Description

A nurse practitioner contacted fresenius to report that an unknown patient on hemodialysis (hd) for renal replacement therapy (rrt) experienced a suspected dialyzer reaction to the optiflux 160nre dialyzer (date not provided).Follow-up with the patient¿s nurse practitioner (np) revealed the patient developed a headache and hypertension (timeline not provided) in conjunction with the utilization of the optiflux 160nre dialyzer.The patient reportedly transitioned to the baxter revaclear dialyzer and did not experience a return of symptoms.The patient did not require hospitalization and has recovered from the events.Subsequent attempts to obtain additional information (e.G.Patient demographics, outpatient home clinic, treatment records, medical records) have thus far proven unsuccessful.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no clinic identifiers were provided, a delivery history search could not be performed to identify specific optiflux 160nre lot numbers.As such, a lot history review or a manufacturing record review could not be performed.The optiflux dialyzer instruction for use indicates the following: ¿in rare cases, thrombocytopenia or hypersensitivity reactions including anaphylactic or anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit, may occur during hemodialysis.Hypersensitivity reactions may cause mild to severe signs and symptoms, including itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest.Patients with a history of hypersensitivity reactions or patients who have a history of being highly sensitive and allergic to a variety of substances should be carefully monitored during treatment.¿ a definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Manufacturer Narrative

Correction: h6; some of the patient codes were inadvertently omitted from the initial submission.

• 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
• MDR Report Key: 10274044
• MDR Text Key: 199307341
• Report Number: 1713747-2020-00286
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention