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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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Reaction (2414)
Event Date 06/19/2020
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: a temporal relationship exists between the use of the optiflux 180nre dialyzer and the event of a dialyzer reaction, characterized by transient hypotension and bradycardia. It is well documented that patients on hemodialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers. The fresenius optiflux f180 nre dialyzer instructions for use 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
It was reported that a hemodialysis (hd) patient had a drop in blood pressure and heart rate, and it was claimed that it was due to a dialyzer reaction. Upon follow-up with the user facility administrator (admin), it was reported that the patient was undergoing hemodialysis (hd) in the intensive care unit (icu). The admin stated that the patient was in the icu for reasons unrelated to hd therapy, however, the reasons were not provided. The admin stated that the patient did not develop and additional symptoms, injury, adverse event, or require medical intervention as a result of the reported event. The patient was able to complete treatment on the same machine with the same supplies. The admin stated the patient¿s doctor wants to try a dialyzer that is sterilized differently than the dialyzer that is currently being used. Additional patient and treatment details were requested but not provided. 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 Key10290083
MDR Text Key199308111
Report Number1713747-2020-00293
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 user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
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?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/17/2020 Patient Sequence Number: 1
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