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 Itching Sensation (1943); Skin Inflammation (2443)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Information received via an external email reported an dialyzer reaction with the optiflux180 dialyzer.Patient developed a rash and welts.Additional information was solicited.

Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.Eight lot numbers were found to be delivered to the customer three months prior to the alleged event.During the lot history review of the eight lots, two lots were noted to have complaints reported against them.Thirteen complaints were for clotting, two were for patient reactions, reported by the same facility as the current investigation, and one for an insect reported in the header of a dialyzer.The production record for each lot identified on the sap search of delivered dialyzers to the customer was reviewed.Three lots had one approved temporary dn on each, two lots had multiple approved temporary dns on each and two lots had multiple approved temporary dns, an ncr and a rework.They are unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls and any other occurrence in production.The lot numbers passed pyrogen testing, were within sterilization dosage parameters, and passed all release criteria.

Event Description

".".

Event Description

Director of quality and performance (dqp) improvement reported this patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) completed their ichd treatment on (b)(6) 2017 without complication, however ¿later in the day¿ (timeline unknown) he called the clinic to report experiencing ¿itching and welts.¿ the patient was advised to take benadryl (dosage unknown), however it was ineffective in relieving the symptoms.The patient was then advised to go to the emergency room (er).The patient presented to the er on (b)(6) 2017 with itching, rashes, and welts on upper torso (specifics unknown).The dqp stated the er reportedly processed blood work (tests unknown), however no chemistry values were reported (reason unknown).The dqp also reported the patient was found to be in a hemolytic state (details unknown).The hospital course and discharge disposition of the patient are unknown.The patient returned to the outpatient dialysis unit on (b)(6) 2017 for their next scheduled treatment.The dqp reported a different size dialyzer, the exeltra 190, was utilized and the treatment occurred without incident.The patient was utilizing an optiflux 250nre dialyzer, and ¿jug¿ based dialysate (value = 2.0 k+ / 3.5 ca) on the date of the event(s).

Manufacturer Narrative

A temporal relationship exists between hd therapy, the optiflux 250nre dialyzer and the reported adverse event(s) of itching, rashes and/or welts on upper torso.A follow-up e-mail from the dqp on (b)(6) 2018 indicated both patients ¿ended up in a hemolytic state.¿ it should be noted itching, rashes and/or welts are not typical signs and/or symptoms associated with an acute hemolysis (johnson, 2015) and any records indicating how the diagnosis was made are currently unavailable.The file indicates the event(s) of itching, rashes and/or welts were singular event(s) as described in a follow-up e-mail received 25/jan/2018.Additionally, neither patient reportedly utilized congruent hd staff, hd machines, hd dialyzer types or sizes, dialysate mixtures, dialysate mode of delivery, and/or presenting symptoms.Based on the information available, causality cannot be fully determined.The patient resumed the use of the optiflux 250nre after utilizing the exeltra 190 for a single hd treatment on (b)(6) 2017, with no additional event(s) noted to date.There no documentation or evidence indicating any fresenius device(s) malfunctioned or did not perform as expected a supplemental report will be submitted upon completion of the plant¿s investigation.

Manufacturer Narrative

Lot number is unknown.A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Clinic reported that the lot number used during the alleged event is unknown.

• 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: 7251257
• MDR Text Key: 99350146
• Report Number: 1713747-2018-00053
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2018

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 Model Number: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Device Catalogue Number: 0500318E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 02/09/2018; 04/09/2018; 05/01/2018
• Supplement Dates FDA Received: 02/14/2018; 04/12/2018; 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention