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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
Catalog Number 0500316E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907)
Event Date 04/12/2019
Event Type  Injury  
Manufacturer Narrative
A temporal relationship exists between ccpd therapy utilizing collective concentrate ¿ naturalyte, the optiflux 160nr dialyzer and the adverse event(s) of asthma like symptoms, characterized by wheezing, shortness of breath, coughing and chest pain. Per the pdrn the etiology of event(s) is unknown; therefore, causality cannot be firmly established. Based on the information available, the collective concentrate ¿ naturalyte and the optiflux 160nr dialyzer cannot be disassociated from the event(s). Given the need for pre-medication to preclude the onset of symptoms during hd therapy, a possible causal or contributory role cannot be ruled out. While uncommon, hypersensitivity reactions are known to occur with use of optiflux dialyzers. Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
A hemodialysis registered nurse (hdrn) for a patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) reported the patient has been experiencing ¿asthma like¿ symptoms during hd therapy (initially documented as post-treatment) for two months (dates not provided) at several different clinics. During follow-up, the hdrn stated the symptoms (e. G. Wheezing, shortness of breath, coughing and chest pain) were mild at first, however they have gotten progressively worse. Emergency medical services was called on 1 or 2 occasions; however, specific dates or additional details were not provided. The patient recently saw a pulmonary specialist and was placed on a steroid inhaler (drug, dosage, frequency not provided). The patient is currently utilizing the steroid inhaler and a nebulizer treatment prior to hd therapy. However, this is not a long-term solution. Additionally, the patient self-medicates with benadryl (dosage not provided) prior to the start of each hd treatment. The patient has been on hd for 1 year and 1 month when these symptoms started occurring and felt there may be some correlation. The patient was scheduled to see an allergist for an acetate patch test on (b)(6) 2019, however during follow-up on (b)(6) 2019, the hdrn stated the patient left town and continued the use of their regular pre-treatment medications to prevent a reaction while traveling. The acetate patch test was rescheduled, so the patient could discontinue utilizing the steroid inhaler. Reportedly both the nephrologist and hdrn feel the patient is having an allergic reaction to the optiflux 160nr dialyzer and are attempting to obtain additional dialyzers to trial. During follow-up, the hdrn stated due to the patient¿s vacation, no alternative dialyzers were trialed. Currently the dialysis staff is performing an extra rinse to attempt to minimize any change of a hypersensitivity reaction.
 
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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
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 Key8578594
MDR Text Key144101201
Report Number1713747-2019-00140
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
Type of Report Initial,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0500316E
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 Received05/10/2019
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: 05/03/2019 Patient Sequence Number: 1
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