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 06/07/2017

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was no indication of any product non-acceptance, deviation, non-conformance, rework, or issues with labeling or process controls, or any other occurrence identified during the manufacturing process which could be associated with the reported event.The lot passed all release criteria.A review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.Additionally, the dialyzer instructions for use (ifu) document is included in each case of fresenius optiflux dialyzer product and cautions the user regarding reactions.Clinical investigation: the documentation in the complaint supports a temporal association between the optiflux 160nre dialyzer and the patient complaints of shortness of breath, chest heaviness, and becoming anxious during hd treatment.In light of the fact that the dialyzer was changed to the baxter exeltra 150 on (b)(6) 2017 with the absence of previous symptoms experienced during hd treatment suggest a possible causal relationship between the complaints of shortness of breath, chest heaviness, and becoming anxious and the optiflux 160nre dialyzer.However, the patient¿s past medical history and comorbid conditions (asthma, pulmonary emphysema, chronic obstructive pulmonary disease (copd), and anemia of chronic disease) cannot be ruled out as possible contributors to the adverse symptoms experienced by the patient.

Event Description

A user facility clinic manager reported that a patient was unable to tolerate hemodialysis (hd) treatment with the fresenius optiflux 160nre dialyzer due to symptoms of shortness of breath, restlessness, chest pain, and anxiety.Follow-up medical treatment information was provided which confirmed that the patient complained of chest heaviness, shortness of breath, and was very anxious after approximately thirty minutes into hd treatment.The patient had requested to stop treatment after approximately one hour to use the bathroom.When the hd treatment was re-started, the blood flow rate (bfr) was lowered and the ultrafiltration (uf) was turned off due to the reported symptoms.The patient was also administered oxygen (o2) at 2 liters per nasal cannula.The patient requested to come off the machine again and treatment was discontinued approximately two hours early due to patient complaints of ¿not feeling good¿ and ¿heart beat too fast.¿ fluid removal was not possible during hd treatment and the patient¿s medical doctor (md) was made aware.The patient¿s vital signs remained stable throughout the hd treatment.The patient reported to feeling better and was able to ¿breathe again¿ after fifteen minutes off of hd treatment.Based on the patient¿s symptoms, the md ordered the patient¿s next hd treatment to use a baxter exeltra 150 dialyzer.During the patient¿s next scheduled hd treatment on (b)(6) 2017, the patient was able to complete treatment without any complaints or symptoms with use of the baxter exeltra 150 dialyzer.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: 6807088
• MDR Text Key: 83128865
• Report Number: 1713747-2017-00268
• 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: 08/21/2017

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 0500316E
• Device Lot Number: 17CU01014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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