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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 0500318E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Reaction (2414)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: based on the available information, it is likely the patient experienced a dialyzer reaction, characterized by itching. It is well-documented that patients on hemodialysis may experience hypersensitivity and allergic reactions due to the dialyzer membrane of various types of dialyzers. The fresenius optiflux 180nre dialyzer instructions for use cautions user of the known risk of hypersensitivity or anaphylactoid reactions to optiflux dialyzers during use. Currently, there is no objective evidence of a dialyzer product deficiency or malfunction associated with the event.
 
Event Description
It was reported a hemodialysis (hd) patient had experienced an allergic reaction involving itchiness while undergoing hd therapy in the outpatient clinic on (b)(6) 2020. The patient was able to complete hd therapy without any further reported issues and was treated with benadryl at 25 mg orally that alleviated the itchiness. The patient did not develop any additional symptoms, injuries, or adverse events as a result of the reported occurrence. There were no reports of anything unusual involving cleaning agents, consumable medical equipment or hemodialysis (hd) therapy. It was confirmed the patient continues hd therapy on the optiflux 180nre without any further dialyzer reactions. It was reported for the patient¿s history of dialyzer reactions, the itching was not severe enough to discontinue hd therapy and the patient has never shown any signs of anaphylaxis. The sample is not available to be returned to the manufacturer for evaluation because it was discarded.
 
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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
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key10076031
MDR Text Key191663988
Report Number1713747-2020-00198
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
Type of Report Initial,Followup,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0500318E
Device Catalogue Number0500318E
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 Received06/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2019
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: 05/20/2020 Patient Sequence Number: 1
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