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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Reaction (2414)
Event Date 11/01/2017
Event Type  Injury  
Manufacturer Narrative
The documentation in this complaint file supports a temporal association between the optiflux 180re dialyzer and complaints of itching (pruritus) which develop during hhd treatment into the post hhd treatment period; the patient received benadryl per mouth; dose unknown. The next hd treatment the dialyzer was changed to baxter exceltra 170 with good effect and no reported itching. It was additionally reported prior to this event of itching the patient had been using baxter dialyzers since (b)(6) 2014 at a previous clinic.
 
Manufacturer Narrative
The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation. As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. A records review was performed on the reported lot. An investigation of the device manufacturing records was conducted by the manufacturer. There were two approved temporary deviation notices noted on the lot; however, they are unrelated to the reported complaint event. There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported complaint. This includes non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint. The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria. Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
 
Event Description
A user facility reported that a patient had experienced itching during and post hemodialysis (hd) treatment with the fresenius optiflux 180nre dialyzer. The patient was administered over-the-counter benadryl. Additionally, the patient has been switched to use a baxter exceltra 170 dialyzer, where the itching has not occurred. The complaint device is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
 
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Brand NameOPTIFLUX 180NRE 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 Key7075841
MDR Text Key256098948
Report Number1713747-2017-00380
Device Sequence Number1
Product Code KDI
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2020
Device Model NumberOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Device Catalogue Number0500318E
Device Lot Number17KU05017
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 Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2017
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: 12/01/2017 Patient Sequence Number: 1
Treatment
DIPHENHYDRAMINE
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