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

Catalog Number 0500318N

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

Patient Problem Reaction (2414)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient had a reaction to a fresenius dialyzer during hemodialysis (hd) treatment.Additional patient, event, and treatment information was requested, but was not provided.

Manufacturer Narrative

Clinical investigation: based on the available information, there is a possible causal association between the fresenius optiflux 180nr dialyzer and the patient¿s reported dialyzer reaction (unknown signs and symptoms).Currently, there is no evidence of a dialyzer product deficiency or malfunction associated with the event.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 180nr dialyzer instructions for use cautions user of the known risk of hypersensitivity or anaphylactoid reactions to optiflux dialyzers during use.Should additional information become available, the clinical investigation will be updated accordingly.

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.One lot was found to have been delivered in this time period.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) which was unrelated to the complaint event.There was no indication of product non-acceptance, 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.Should additional relevant information become available, a supplemental report will be submitted.

• 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; 475 west 13th street; ogden UT 84404
• MDR Report Key: 8199892
• MDR Text Key: 131514162
• Report Number: 1713747-2018-00503
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K002277
• 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,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0500318N
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention