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); Rash (2033); Swelling (2091)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility hemodialysis (hd) patient reported during hemodialysis treatment the patient became symptomatic with a rash on his face, back, chest, and arms as well as swelling of the lips while on treatment.The patient's treatment was shortened because of the symptoms.Per rn the patient had been using the fresenius optiflux 180 nr dialyzer at the time of the event.The patient had been receiving dialysis since (b)(6) 2011 and had been using fresenius dialyzers.The patient remained symptomatic for the next few days and went to the emergency room (er) from home on (b)(6) 2018 as a precaution.The patient was given a prescription for prednisone and was also advised to take benadryl.Per rn the patient was not admitted to the hospital and was sent home from the er.Additional follow-up made with the rn on 03/15/2018 revealed the patient was given a prescription (date unknown) for prednisone (dosage and frequency unknown) to take while waiting for the exeltra 170 dialyzer to be delivered.The patient underwent hemodialysis (hd) treatments on (b)(6) 2018 without incident.The rn stated the exeltra 170 dialyzer was available for hd treatment on (b)(6) 2018, and the treatment was completed without incident.The patient's dialysis treatment related medications (i.E.Hectorol) continued to be held.

Manufacturer Narrative

Conclusion: there is a temporal relationship between the hd treatment and the fresenius optiflux 180nre dialyzer on (b)(6) 2018 and the reported adverse reports rash and itching which required subsequent treatment with prednisone and benadryl on (b)(6) 2018.While uncommon, hypersensitivities reactions are known to occur with use of optiflux dialyzers.Additionally, hypersensitivity reactions have been known to occur months, even years after use with the same dialyzer model during additional follow-up it was reported the patient was given prednisone prior to hd therapy on 03/09/2018 and 03/12/2018 and was able to complete treatment without complaint(s).Additionally, the patient was changed to a baxter exeltra 170 on (b)(6) 2018 and completed treatment without complaint(s), thus indicating a strong possibility the patient may have experienced a hypersensitivity reaction to the optiflux 180nre dialyzer.However the patient also received iv hectorol 1,000 mcg, prior to the reported event(s) of rash and itching; both of which are documented hypersensitivity reactions to hectorol.Therefore based on the proximity of these two factors, causality cannot fully be determined.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Information in the complaint file and records were reviewed by a post market surveillance clinician.On (b)(6) 2018 an registered nurse (rn) stated this patient with end stage renal disease (esrd) on hemodialysis (hd) experienced itching (location unknown) and a rash (severity and location unknown) while receiving hd therapy on (b)(6) 2018.The rn stated the patient had been utilizing an optiflux 180nre dialyzer since 03/04/2011 and has experienced a shortened treatment.A follow-up e-mail was received on (b)(6) 2018 from the rn stated the patient was able to complete treatment on (b)(6) 2018, as the event(s) occurred at the end of the hd treatment.No treatment data was presently available.Reportedly the patient experienced itching and a rash, and eventually went to the emergency room (er) on (b)(6) 2018 (discharge date unknown) as the event ¿continued to bother¿ him.The hospital course and discharge disposition of the patient were unknown.The rn reported the patient received a prescription for prednisone (dosage, duration and frequency unknown) and was told to take benadryl (dosage, duration, and frequency unknown).

Manufacturer Narrative

The reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Twelve lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There were two approved temporary deviation notices (dns) reported on two of the lots which were unrelated to the complaint event.There was one approved temporary dn reported on eight of the lots which was unrelated to the complaint event.Additionally, there was one approved temporary dn and one approved nonconformance report (ncr) on two of the lots which were unrelated to the reported 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 lots 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: 7342771
• MDR Text Key: 102524972
• Report Number: 1713747-2018-00088
• 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,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0500318E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; HYDROXYZINE; LEVOTHYROXINE; METAMUCIL; NEPRO CARB STEADY; PREDNISONE; PROTONIX; RENAPLEX; ASPIRIN; HYDROXYZINE; LEVOTHYROXINE; METAMUCIL; NEPRO CARB STEADY; PREDNISONE; PROTONIX; RENAPLEX
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 94 YR
• Patient Weight: 89