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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); Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Event Date 07/20/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility reported that a patient had chest pains during their hemodialysis (hd) treatment which subsequently subsided when the treatment was terminated. Upon follow up, the clinical manager reported that the patient had chest pains due to a dialyzer reaction during their therapy which went away after the treatment was over. The clinical manager stated that the patient did not receive any medical intervention for the chest pains, including medications or hospitalization as the chest pains resolved on their own. The clinical manager reported that the chest pains were attributed to the dialyzer and the patient was subsequently switched to a new type of dialyzer instead. Per the clinical manager, this was the only event that occurred with the patient related to a dialyzer reaction and the patient has been dialyzing since (b)(6) 2017. The patient is continuing with hemodialysis therapy using the new dialyzer without issue and without reoccurrence of the reported event. The dialyzer was discarded and is not available to be returned.
 
Manufacturer Narrative
A temporal relationship exists between the hemodialysis (hd) therapy utilizing the optiflux f160nre dialyzer, and the patient¿s adverse event of chest pain. The information received supports a probable association between the fresenius optiflux f160nre dialyzer, and the patient¿s adverse event. It was reported the patient transitioned to a new dialyzer, after which there were no additional complaint(s); thus indicating a strong possibility the patient experienced a hypersensitivity reaction to the optiflux f160nre dialyzer. While uncommon, hypersensitivity reactions are known to occur with use of optiflux dialyzers. Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model. 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 one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event. 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.
 
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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 Key7775788
MDR Text Key116857641
Report Number1713747-2018-00294
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
Type of Report Initial,Followup
Report Date 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number0500316E
Device Lot Number18AU06033
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 Received08/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2018
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: 08/12/2018 Patient Sequence Number: 1
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