• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500318E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 08/14/2018
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 clinic manager reported a patient who broke out in hives during the last hour of their (b)(6) 2018 hemodialysis treatment. The fresenius optiflux 180nre dialyzer finished assy was replaced with an optiflux 180nr dialyzer finished assmbly, and the patient was administered 12. 5mg of benadryl intravenously. The patient successfully completed treatment. The complaint device was reportedly discarded and was not available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Clinical investigation: it was reported that on (b)(6) 2018 this patient on thrice weekly hemodialysis (hd) developed hives during their treatment. It was reported the patient was initially thought to be having an allergic reaction to the gloves in use; however, it was later suspected the patient was having an allergic reaction to the optiflux nre dialyzer in use during the treatment. It was first reported that the patient was administered 25 milligrams (mg) benadryl intravenously; however, the clinic¿s subsequent response confirmed that the patient did not receive any medical intervention. Nonetheless, the patient¿s symptoms reportedly resolved after the hd treatment. The patient¿s dialyzer was subsequently changed to the optiflux 180 nr and the patient continued regularly scheduled hd treatments. Based on the available information, there is a likely causal association between the fresenius optiflux180nre dialyzer and the patient¿s allergic reaction (characterized by hives during the hd treatment). Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis. There is no evidence of an optiflux nre dialyzer product deficiency or malfunction. Should additional information become available, please resubmit for a clinical review and the clinical investigation will be updated accordingly.
 
Manufacturer Narrative
Updated to optiflux 180nre dialyzer. Clinical investigation: on (b)(6) 2018, it was reported that on (b)(6) 2018 this patient on thrice weekly hemodialysis (hd) developed hives during their treatment. It was reported the patient was initially thought to be having an allergic reaction to the gloves in use; however, it was later suspected the patient was having an allergic reaction to the optiflux nre dialyzer in use during the treatment. The patient was administered 25 milligrams (mg) benadryl intravenously and the patient¿s symptoms resolved after the hd treatment. The patient¿s dialyzer was subsequently changed to the optiflux 180 nr and the patient continued regularly scheduled hd treatments. The patient had been on hd therapy for 7 months. Based on the available information, there is a likely causal association between the fresenius optiflux180nre dialyzer and the patient¿s allergic reaction (characterized by hives during the hd treatment). Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis. There is no evidence of an optiflux nre dialyzer product deficiency or malfunction. 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 lots. An investigation of the device history records (dhr) was conducted by the manufacturer. Two lots had one approved temporary dn and two lots had multiple approved temporary dns. They are unrelated to the reported 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTIFLUX 180NRE 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 Key7971237
MDR Text Key123935573
Report Number1713747-2018-00410
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,Followup,Followup
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number0500318E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/16/2018 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
-
-