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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
Model Number 0500316E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Vomiting (2144); Loss of consciousness (2418)
Event Date 05/24/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: a temporal relationship exists between the use of the optiflux 160nre dialyzer and the event of a dialyzer reaction, characterized by vomiting, hypotension, loss of consciousness and pruritis. It is well documented that patients on hd therapy may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers. In the optiflux instructions for use, it cautions users of the known risk of adverse reactions such as ¿itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest¿. Based on the available information, there is no allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s serious adverse events.
 
Event Description
A purchasing manager reported to fresenius customer service that a patient on hemodialysis (hd) therapy utilizing an optiflux 160nre dialyzer experienced a dialyzer reaction. There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s). Upon follow up with an hd registered nurse (hdrn), it was reported this patient experienced vomiting, hypotension, loss of consciousness and pruritis during an hd treatment on (b)(6) 2021. The patient was not hospitalized for this event and was given prednisone and diphenhydramine (unknown route, dose, frequent and duration). The patient is stable and continuing their regular hd therapy. The exact cause of the patient¿s allergic reaction and associated symptoms were unknown; however, it was confirmed this event was not related to a deficiency or malfunction of any fresenius device(s) or product(s). The dialyzer used for the event was not available to be returned for manufacturer 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
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 Key11989181
MDR Text Key255936712
Report Number1713747-2021-00181
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0500316E
Device Catalogue Number0500316E
Device Lot Number21AU06010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2021
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: 06/13/2021 Patient Sequence Number: 1
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