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 Problem Reaction (2414)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility charge nurse reported a hemodialysis patient who complained of mild itching at the start of their (b)(6) 2018 hemodialysis treatment using a fresenius optiflux 180nre dialyzer.Upon follow up with the charge nurse, it was confirmed the patient was administered a one-time dose of benadryl (12.5mg) via an access needle, and confirmed the patient completed treatment with the same machine using the same dialyzer.It was confirmed the dialyzer was discarded and is not available for return.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: on (b)(6)2018 a user facility submitted an electronic adverse event form against an optiflux dialyzer, reporting this 55-year-old male patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) experienced a suspected dialyzer reaction on (b)(6)2018.Follow-up with the user facility revealed the patient experienced mild itching at the start (exact timeline not provided) of hd therapy on (b)(6)2018.The patient was given a single intravenous dose of benadryl 12.5 mg with good effect and completed the hd treatment utilizing the same hd machine and optiflux 180nre dialyzer.No sample was retained for manufacturer evaluation.Additional information was requested but not furnished.A temporal association exists between hd therapy utilizing the optiflux f180nre dialyzer, and the patient¿s adverse event(s) of hypersensitivity and/or allergic reaction requiring medicinal intervention.The documentation in this complaint file supports a probable association between the fresenius optiflux f180nre dialyzer, and the patient¿s adverse event(s).It was reported the patient was given benadryl, after which there were no additional complaint(s); thus, indicating a strong possibility the patient experienced a hypersensitivity and/or allergic reaction to the optiflux f180nre dialyzer on 12/13/2018.While uncommon, hypersensitivity reactions are known to occur with use of optiflux dialyzers.Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.

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.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 approved temporary deviation notice (dn) reported on three of the lots which were unrelated to the complaint event.There are no complaints against any of the lot numbers related to itching or a dialyzer reaction.The production record review showed there was one nc during the production of one lot, which was unrelated to the reported event.There was no indication of product nonacceptance, deviation, 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.Should additional relevant information become available, a supplemental report will be submitted.

• 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; 475 west 13th street; ogden UT 84404
• MDR Report Key: 8197185
• MDR Text Key: 131442387
• Report Number: 1713747-2018-00502
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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
• Device Age: MO
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR