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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); Anxiety (2328)
Event Date 05/19/2020
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 hd therapy utilizing the fresenius combi set bloodlines, optiflux 160nre dialyzer and the serious adverse events of dialyzer reaction, wheezing and anxiety, which required emergent discontinuation of hd therapy. The definitive etiology of the events is unknown; therefore, causality cannot be firmly established. However, given the patient¿s wheezing and anxiety during hd therapy, a possible causal or contributory role cannot be excluded. Based on the information available, the fresenius combi set bloodlines and/or optiflux 160nre dialyzer cannot be disassociated from the events. While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit. Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.
 
Event Description
It was reported that a hemodialysis (hd) patient experienced a suspected allergic reaction (per the nephrologist) to the fresenius combi set bloodlines. Follow-up with the patient¿s inpatient dialysis program manager (idpm) revealed the patient was hospitalized on (b)(6) 2020 for hyperkalemia, acute kidney failure (due to cancer, specifics not provided) and dyspnea. On (b)(6) 2020, the patient underwent a temporary hemodialysis (hd) catheter (not a fresenius product) placement and was started on intermittent hd while being monitored by telemetry in the intensive care unit (icu). The patient was alert and oriented, and after hd was initiated on (b)(6) 2020, the patient began wheezing and feeling an overwhelming sense of anxiety or ¿impending doom. ¿ initially it was felt the patient may be having a reaction to the fresenius combi set bloodlines, however further evaluation revealed the likely source of the allergic reaction to be caused by the sterilization methods of the optiflux 160nre dialyzer. The patient¿s treatment was discontinued; however no additional information was provided. The treatment record was requested; however, the request was declined. The combi set product information was not provided.
 
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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 Key10136409
MDR Text Key194798800
Report Number1713747-2020-00230
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,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0500316E
Device Catalogue Number0500316E
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 Received06/23/2020
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: 06/09/2020 Patient Sequence Number: 1
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