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 Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Pain (1994); Reaction (2414)

Event Date 01/14/2019

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, there is a likely causal association between the fresenius optiflux 180nre dialyzer and the patient¿s dialyzer reaction characterized by dyspnea, chest pain, back pain, abdominal discomfort and hypotension.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 180nre dialyzer instructions for use cautions user of the possible risk of hypersensitivity or anaphylactoid reactions to optiflux dialyzers during use.The dialyzer in use was not returned to the manufacturer for further investigation.Currently, there is no evidence of a dialyzer product deficiency or malfunction associated with the event.Should additional information become available, the clinical investigation will be updated accordingly.

Event Description

A hemodialysis patient complained of abdominal discomfort, weakness, back pain, hypotension, and chest pain approximately 90 minutes after beginning their treatment.As a result, the hd treatment was ended and the patient¿s blood which circulated in the blood circuit was not re-infused (standard of practice) which resulted in approximately 250-300 cc of blood loss.The patient was seen and evaluated by a doctor, and was then sent to the hospital for further evaluation.Upon follow up, the user facility clinical manager stated that the patient went to the hospital emergency room via emergency medical services (ems) for observation.The patient was not admitted to the hospital.The patient's symptoms were determined to be a dialyzer reaction and that their prescription has since been changed.The patient has continued their hemodialysis therapy without further incident.Additional patient, event, and hospital course information was requested, but was not available.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.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 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 lot 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 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: 8261748
• MDR Text Key: 133722831
• Report Number: 1713747-2019-00024
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 0500318E
• Device Lot Number: 18NU03012
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 108