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

Catalog Number 0500318E

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: there is a temporal relationship between hemodialysis (hd) therapy with the fresenius optiflux 180nre dialyzer and the reported event of confusion, hypotension, diaphoresis and poor responsiveness. While uncommon, hypersensitivity reactions are known to occur with use of optiflux dialyzers. Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model. It was reported the patient was changed to a different dialyzer and completed treatment without complaint(s), thus indicating a strong possibility the patient may have experienced a hypersensitivity reaction to the optiflux 180nre dialyzer.

Event Description

A user facility reported a dialyzer reaction that occurred approximately fifteen (15) minutes into the patient¿s second hemodialysis (hd) treatment. Treatment was initiated at 9:45 am and at approximately 10:00 am the patient became hypotensive, poorly responsive, confused, and diaphoretic (values and details unknown). The patient¿s treatment was discontinued and all blood returned. It was reported that the patient recovered post treatment. The clinic stated that the patient continued with hemodialysis therapy at their next scheduled treatment(s) with the use of a new dialyzer and with no issues and without reoccurrence of the reported issue. No information regarding what type of dialyzer the patient was transitioned to was provided. Additionally, it was reported that while the patient has end stage renal disease (esrd), the patient has elected to discontinue dialysis therapy altogether. It was reported that the patient¿s condition is being managed without the use of renal replacement therapy (rrt). Additional information was requested regarding the patient and the reported event, however, the information was not provided by the clinic. The complaint device is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: 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.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• 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: 7409926
• MDR Text Key: 104801717
• Report Number: 1713747-2018-00115
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 0500318E
• Device Lot Number: 17PU04004
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 04/09/2018 Patient Sequence Number: 1