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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 Dyspnea (1816); Itching Sensation (1943); Reaction (2414)
Event Date 05/04/2018
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 user facility reported that a patient had an allergic reaction to a fresenius dialyzer during their first hemodialysis (hd) treatment. Approximately fifteen (15) minutes into the hemodialysis therapy, the patient began itching, and became flushed and short of breath. The patient was administered 50 mg benadryl via intravenous (iv) route and patient's blood rinsed back and treatment discontinued. The patient recovered shortly after and the doctor advised to reset the patient up with new supplies. Approximately thirty (30) minutes into the initiation of the second attempt at the treatment, the patient began itching and having a reaction again. The patient was administered another 50 mg of benadryl via iv and was able to complete their three hour hd treatment. Per the clinical manager, the patient did have some skin blisters due to the reaction, however, recovered fully in the clinic and was sent home. The clinical manager stated that the patient has been able to continue hd therapy using a revaclear dialyzer without issue or reoccurrence of the reported event. The clinical manager stated that there was no issue against the fresenius dialyzer, just that the patient was allergic to it. Additional patient and treatment information was requested, however, not provided. The complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Clinical investigation in clinical investigation: a probable causal association exists between the fresenius optiflux 160nre dialyzer and the patient¿s allergic reaction, characterized by dyspnea and pruritus, which resolved after administration of iv benadryl (outpatient). Although rare, it is known that hypersensitivity or anaphylactoid reactions to optiflux dialyzers can occur during hemodialysis (hd) therapy. The patient was subsequently switched to a revaclear dialyzer and reportedly continues hd therapy without further reoccurrence of allergic events. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
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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
475 west 13th street
ogden UT 84404
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7567699
MDR Text Key110028700
Report Number1713747-2018-00174
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100149
UDI-Public00840861100149
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
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number0500316E
Device Lot Number17NU06001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2017
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: 06/04/2018 Patient Sequence Number: 1
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