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

Model Number 0500318N

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

Patient Problems Itching Sensation (1943); Reaction (2414)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: based on the available information, it is likely the patient experienced a dialyzer reaction, characterized by itching.It is well-documented that patients on hemodialysis may experience hypersensitivity and allergic reactions due to the dialyzer membrane of various types of dialyzers.The fresenius optiflux f180 nr dialyzer instructions for use cautions user of the known risk of hypersensitivity or anaphylactoid reactions to optiflux dialyzers during use.Currently, there is no objective evidence of a dialyzer product deficiency or malfunction associated with the event.

Event Description

A hemodialysis (hd) nurse reported a hd patient had experienced a reaction from the optiflux f180nr dialyzer involving itchiness during hd therapy in the outpatient clinic.Upon follow up with the hd registered nurse (hdrn), it was confirmed this patient had experienced an allergic reaction involving itching while undergoing hd therapy on (b)(6) 2019.The patient was able to complete hd therapy without any further reported issues and was treated with benadryl 25 mg orally that alleviated the itchiness.The patient did not develop any additional symptoms, injuries, or adverse events as a result of the reported occurrence.There were no reports of anything unusual involving cleaning agents, consumable medical equipment or hemodialysis (hd) therapy.The hdrn indicated an allergic reaction to the dialyzer was suspected and due to the reaction, the dialyzer was changed to the optiflux 180nre in efforts to find a more biocompatible dialyzer for all future hd treatments.It was reported the itchiness was not severe enough to discontinue hd therapy and the patient has never shown any signs of anaphylaxis.It was confirmed the patient continues hd therapy on the optiflux 180nre without any further adverse events.

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 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.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 180NR DIALYZER FINISHED ASSMBLY
• 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: 10073261
• MDR Text Key: 191530950
• Report Number: 1713747-2020-00196
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (y/n): N
• PMA/PMN Number: K002277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0500318N
• Device Catalogue Number: 0500318N
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS HD MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 69