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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500318N
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 09/04/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: on 09/23/2018, it was reported that on (b)(6) 2018 this patient on thrice weekly hemodialysis (hd) was suspected to have an allergic reaction to the optiflux 180nr dialyzer, characterized by hives during the last hour of hd treatment, despite the dialyzer being flushed with 2 liters of normal saline during treatment set up. The patient has a history of suspected optiflux 180nre dialyzer reaction on (b)(6) 2018 which is further addressed under (b)(4). During follow-up, it was confirmed the patient received a total of 25 milligrams (mg) benadryl during the hd treatment, which was part of the patient¿s standing hd orders. The patient was able to complete their treatment and the patient¿s hives resolved without further reported medical intervention. The patient continues with their normal dialysis treatments, unknown dialyzer product, without further reported allergic events. Based on the available information, there is a likely causal association between the fresenius optiflux 180nr dialyzer and the patient¿s allergic reaction (characterized by hives during the last hour of hd treatment). Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis. There is no evidence of an optiflux nr dialyzer product deficiency or malfunction.
 
Event Description
A user facility clinic manager reported a patient who broke out in hives during the last hour of their (b)(6) 2018 hemodialysis treatment. The dialyzer and bloodlines were primed with additional normal saline solution. The patient was administered 12. 5mg of benadryl twice intravenously during treatment. The patient successfully completed treatment on the machine, and continues with their scheduled hemodialysis treatments. The complaint device was reported to be available to be returned to the manufacturer for evaluation.
 
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) reported on the lot which was 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 180NR DIALYZER FINISHED ASSMBLY
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 Key7955600
MDR Text Key123371850
Report Number1713747-2018-00375
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K002277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number0500318N
Device Lot Number18BU04009
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/11/2018 Patient Sequence Number: 1
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