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U.S. Department of Health and Human Services

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

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OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NameOPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Type of DeviceDIALYZER, 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 Key6807088
MDR Text Key83128865
Report Number1713747-2017-00268
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100149
UDI-Public00840861100149
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
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
Date FDA Received08/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number0500316E
Device Lot Number17CU01014
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/21/2017 Patient Sequence Number: 1
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