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 Chest Pain (1776); Dyspnea (1816); Anxiety (2328)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: the documentation in this complaint supports a temporal association between the optiflux 160nre dialyzer and the patient¿s complaints of shortness of breath, chest pain, and becoming anxious during hemodialysis (hd) treatment.However, it is documented in the clinical record that an allergy to the dialyzer remains unconfirmed.Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation and a lot number was not provided.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A search was performed of product lot numbers for the reported dialyzer catalog number (0500316e) that were shipped to the hospital facility for the three (3) month time frame which immediately preceded the event occurrence date.The search found no lots delivered to the facility within this time frame.The manufacturer performed an additional search in order to obtain the most recently received lot number for this facility and no results were yielded for any dialyzer product from the occurrence date to three years prior.As such, no product records could be reviewed.As a sample has not been provided for evaluation, a definitive conclusion regarding the complaint incident cannot be determined.Additionally, the dialyzer instructions for use (ifu) document is included in each case of fresenius optiflux dialyzer product and cautions the user regarding reactions.

Event Description

A user facility clinic manager reported that while a hemodialysis (hd) patient was hospitalized from (b)(6) 2017 for shortness of breath and fluid overload, the patient received scheduled hd therapy on (b)(6) 2017 and experienced reactions with use of a fresenius optiflux 160nre dialyzer.The patient¿s treatment ended approximately 50 minutes early at 12:19 pm.The patient was reportedly unable to tolerate the hd treatment due to symptoms of anxiety and shortness of breath.During hd treatment, the patient also complained of chest pain which resolved after the administration of nitroglycerine and oxygen.At the end of treatment, the patient was reported to be ¿feeling bad¿.The hospital originally attributed these symptoms to the patient¿s use of the medication bumex and the patient¿s condition of chronic obstructive pulmonary disease (copd).The patient¿s hd clinic informed the hospital that the patient had previously experienced the same symptoms during hd treatment at the clinic with use of the fresenius optiflux 160nre dialyzer, but the patient was changed to the baxter exeltra 150 dialyzer on (b)(6) 2017 prior to the patient¿s hospital admission, and hd treatment was better tolerated by the patient.No malfunction of the fresenius dialyzer in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event.The complaint device has not been returned to the manufacturer for evaluation.

• 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; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6829624
• MDR Text Key: 83942300
• Report Number: 1713747-2017-00280
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2017

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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 99