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

Model Number OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 09/06/2018

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 clinical manager reported a patient who broke out in hives for an unspecified number of hemodialysis treatments occurring after (b)(6) 2018 while using fresenius optiflux dialyzers. The clinic manager confirmed the patient had been administered 12. 5mg of benadryl intravenously, and remained on the machine to complete treatment, after which their symptoms resolved. The clinic manager advised the patient had not missed any of their scheduled hemodialysis treatments due to the issue. Due diligence attempts were exhausted, but additional patient and device information was not provided.

Manufacturer Narrative

Additional information: event description updated. Brand name updated. Medical device -model # and catalog # updated.

Event Description

Updated event description: a user facility clinical manager reported a patient who broke out in hives for an unspecified number of hemodialysis treatments occurring after (b)(6) 2018 and before (b)(6) 2018 while using fresenius optiflux 180nr dialyzers. The clinic manager confirmed the patient had been administered 12. 5mg of benadryl intravenously prior to treatment, and remained on the machine to complete treatment, after which their symptoms resolved. The clinic manager advised the patient had not missed any of their scheduled hemodialysis treatments due to the issue.

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 were two approved temporary deviation notices (dns) 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.

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: the hemodialysis patient had a medical history of end stage renal disease (esrd). Based on the available information, there is a likely causal association between the fresenius optiflux 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 dialyzer product deficiency or malfunction reported for this event.

• Brand Name: OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 8055621
• MDR Text Key: 126683252
• Report Number: 1713747-2018-00446
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
• Device Catalogue Number: 0500318N
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/09/2018 Patient Sequence Number: 1

Treatment

FRESENIUS BLOODLINES; FRESENIUS DIALYSIS MACHINE; FRESENIUS BLOODLINES; FRESENIUS DIALYSIS MACHINE