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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); Reaction (2414)
Event Date 09/13/2018
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 registered nurse (rn) reported that a patient had an allergic reaction to the dialyzer. Upon follow up, the charge nurse stated that the patient had started their first hemodialysis (hd) treatment at the clinic using an optiflux 160nre dialyzer. The charge nurse that after the initiation of the treatment, the patient was reportedly restless with shortness of breath. The blood was returned to the patient and the treatment was subsequently cancelled. Per the charge nurse, there was no medical intervention for the symptoms as they subsided on their own after ending the treatment. The patient went to the emergency room (er) for evaluation, however was not treated or admitted. The charge nurse stated that they believed the patient was having a dialyzer reaction and was switched to a new dialyzer for their next treatment. The charge nurse stated that with the new dialyzer the patient completed their next treatment without issues. The patient has continued their hd therapy utilizing the new dialyzer since the event. The complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
There is a temporal relationship between the patient event of restlessness and shortness of breath and hemodialysis (hd) therapy with the optiflux 160nre dialyzer. In rare cases, persons with hypersensitivity to the polysulphone membranes and/or e-beam sterilization are at risk for anaphylactic or anaphylactoid reactions. Hypersensitivity reactions may cause mild to severe signs and symptoms, including: itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest. The patient has continued hd therapy utilizing an unspecified baxter dialyzer without any further complications. Although the patient experienced a reaction, there is no allegation of a product malfunction or deficiency related to this event. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Manufacturer Narrative
The reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation. A production records review was performed on the reported lot. An investigation of the device history records (dhr) was conducted by the manufacturer. There was one approved temporary deviation notice (dn) and nonconformance report (ncr) reported on the lot which were unrelated to the complaint event. There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event. The lot met all release criteria. A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device. Therefore, the complaint is not confirmed.
 
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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
MDR Report Key7925537
MDR Text Key122314458
Report Number1713747-2018-00360
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Catalogue Number0500316E
Device Lot Number18DU01014
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received10/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/02/2018 Patient Sequence Number: 1
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