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

Model Number OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

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

Patient Problems Dyspnea (1816); Swelling (2091); Reaction (2414)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: based on the available information, there is a temporal and a likely causal relationship between the fresenius optiflux 180nre dialyzer and the patient¿s reaction (characterized by tongue swelling, shortness of breath and difficulty talking 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 180nre dialyzer product deficiency or malfunction.Additionally, although the patient experienced an adverse reaction during treatment, there is no allegation of a product malfunction or deficiency related to this event.

Event Description

A user facility clinical manager reported a hemodialysis (hd) patient attended regularly scheduled dialysis treatment.Pre vs 118/78, pulse 106, temp 99.1.At approximately 10:34 dialysis initiated via a left upper arm avf.Within approximately 20 minutes, the patient stated that the tongue was swelling.The patient also had shortness of breath and difficulty speaking.Oxygen was provided, 911 called, and dialysis was terminated.Blood pressure 103/64, pulse 104.The patient was transported to the emergency room and later released.The patient recovered.Upon follow up, the clinical manager stated the patient did not experience any reaction until the treatment on (b)(6) 2019 with use of the optiflux 180nre dialyzer (the same dialyzer used for all previous treatments).The patient did not require hospital admission and was in the emergency room (er) for less than 24 hours prior to being discharged.The treatment received in the er is unknown.The patient continued hd treatment afterwards.

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 other complaint reported against the lot.The complaint involved a reaction reported by the same patient.No other customers have reported any complaints, including allergic reaction type events, against this lot number.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: 9140423
• MDR Text Key: 167018669
• Report Number: 1713747-2019-00308
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Device Catalogue Number: 0500318E
• Device Lot Number: 19HU03017
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 108