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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number OPTIFLUX DIALYZER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Malaise (2359)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A clinical support specialist reported that a hemodialysis (hd) patient experienced a headache and felt ¿very tired¿ (malaise) following completion of hd therapy [date(s) not provided]. The patient reportedly felt these symptoms after dialyzing with a fresenius optiflux dialyzer. Consequently, the user facility trialed the nipro elisio dialyzer and the symptoms disappeared. The patient had previously utilized a baxter revaclear dialyzer for treatment, when they were being treated at a (b)(6) clinic. Upon follow up with the clinic manager (cm), it was reported that the patient has continued to utilize the nipro elisio dialyzer with no further complaints of headache or malaise. Multiple attempts have been made to obtain additional information from the cm, related to the reported event. At this time, no further information has been provided.
 
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Brand NameOPTIFLUX DIALYZER
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 Key9549427
MDR Text Key174408683
Report Number1713747-2020-00002
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,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberOPTIFLUX DIALYZER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received02/06/2020
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: 01/03/2020 Patient Sequence Number: 1
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