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

Catalog Number 0500316E

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414); Loss of consciousness (2418)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd therapy utilizing the optiflux 160nre dialyzer and the serious adverse events of loss of consciousness, hypersensitivity and allergic reaction, which required emergent discontinuation of hd therapy and resulted in hospitalization.The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.However, given the patient¿s loss of consciousness during hd therapy, and the favorable response to the nxstage streamline express during the patient¿s last two treatments, 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.Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.

Event Description

It was reported that a hemodialysis (hd) patient lost consciousness during their hd treatment on (b)(6) 2019.Upon follow up with the patient¿s registered nurse (rn), it was revealed that the patient was hospitalized following the event; a diagnosis was not provided.The rn stated the patient experienced a severe dialyzer reaction to the fresenius optiflux 160 nre, and briefly lost consciousness.Specifics pertaining to the loss of consciousness were not provided.The treatment was immediately halted, and the patient lost approximately 300 ml of blood during the termination of their treatment.The patient was given approximately 500 ml of normal saline during the event and recovered quickly.The patient's nephrologist ordered a ¿nxstage streamline express,¿ which is a dialyzer with pre-attached blood lines.The patient has undergone approximately two treatments utilizing the product without further intervention.Multiple attempts to obtain treatment records, hospital records, and patient demographics were unsuccessful.

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.The search yielded no results.The search was then extended to find the last delivered lot with the reported catalog number.There were no results.There were no other patient identifiers provided, and the delivery history search did not aid in identifying specific dialyzer lot numbers; therefore, a lot history review or a record review could not be performed.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 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: 9527873
• MDR Text Key: 173450606
• Report Number: 1713747-2019-00395
• 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
• Report Date: 01/16/2020

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: 0500316E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention