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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
Catalog Number 0500318E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Reaction (2414)
Event Date 04/11/2017
Event Type  Injury  
Manufacturer Narrative
The clinical investigation and plant evaluation are in process. A supplemental medwatch report will be submitted upon completion of these activities.
 
Event Description
A facility clinic manager reported the patient had excessive itching with the use of the dialyzer. During follow up with the clinic manager (cm), this patient's first date of hemodialysis (hd) was (b)(6) 2017 using another manufacturer's dialyzer. No adverse effects were experienced during the patient's initial hd therapy and the patient was discharged home to continue receiving regularly scheduled outpatient hd treatments. During the first hd therapy performed at the user facility, the patient complained of severe itching within minutes of treatment initiation. No other symptoms were reported. The patient was administered 50 milligrams (mg) of intravenous (iv) benadryl, but within minutes the treatment was discontinued due to the severe itching. Treatment was not resumed so the patient was discharged home. The patient returned for the next scheduled hd treatment. The dialyzer was changed to the optiflux 180nr dialyzer assembly product for their next scheduled hd therapy, and the treatment was completed without issue. No patient adverse effects were experienced following the change to the dialyzer, and all subsequent treatments have been performed using this dialyzer without issue. The complaint device was available to be returned to the manufacturer for analysis.
 
Manufacturer Narrative
Plant inv: the device was returned to the manufacturer for physical evaluation. A visual examination of the returned device revealed that the fibers were wet with indication of blood exposure. No cracks, damage, or irregularities were observed. The dialysate/blood ports were found to be undamaged and without defect. The polyurethane material remained intact and inspection of all molded components did not indicate any defects that would have caused improper mating between parts. Further examination of the fiber bundle did not reveal any damage or irregularities; specifically, no broken, kinked, looped, or damaged fibers. A review of the device manufacturing records was conducted by the manufacturer. There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event. The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint. Additionally, the dialyzer instructions for use (ifu) document cautions the user of potential hypersensitivity reactions including itching. The investigation into the cause of the patient incident was not able to confirm an issue which would have resulted in the adverse event. Analysis of the complaint device did not identify any damage, irregularities, or defects that would affect the integrity or performance of the dialyzer unit. Clinical inv: a clinical investigation was performed by a specialist to identify a causal relationship between the between the optiflux dialyzer and the adverse event. The clinician concluded that the documentation in the complaint file supports a probable association between the optiflux 180nre dialyzer assembly and the itchiness. Specifically in light of the fact that once the dialyzer was changed to the optiflux 180nr, there were no further reports of patient itching.
 
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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 Key6555526
MDR Text Key74789058
Report Number1713747-2017-00130
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number0500318E
Device Lot Number17BU03011
Other Device ID Number00840861100156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2017
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: 05/09/2017 Patient Sequence Number: 1
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