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)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A user facility hemodialysis (hd) registered nurse (rn) reported a hemodialysis patient's treatment was shortened after the patient developed symptoms of a rash on the patient's neck, chest, and arms.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 hd patient was taken off treatment as soon as symptoms occurred.He was pre-treated at the beginning of treatment with benadryl and the dialyzer was flushed with 2000ml of normal saline prior to treatment as well.The patient did not wish to go to the hospital on this day and his only symptoms on this day were a rash on the neck, chest, and arms.The nephrologist ordered prednisone for the patient to take every treatment until the exception dialyzer arrived.The patient went to his following hemodialysis treatment without further issue.Additional follow-up made with the rn on (b)(6) 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.

Event Description

Information in the complaint file and appended records were reviewed by a post market surveillance clinician.On (b)(6) 2018 a registered nurse (rn) in reported this patient with end stage renal disease (esrd) on hemodialysis (hd) thrice experienced a rash on neck, chest and arms (severity unknown) while receiving hd therapy on (b)(6) 2018.The rn stated the patient has been utilizing an optiflux 180nre dialyzer since (b)(6) 2011 and has experienced a shortened treatment.The rn stated the patient had not been trialed on a ¿non-fmc¿ dialyzer yet, however the exeltra 170 dialyzer had been ordered and was expected for the patient¿s next treatment on (b)(6) 2018.Additionally, all medication normally given to the patient during hd are being held until the patient was no longer having reactions.The patient was pretreated with benadryl (dosage unknown), and the optiflux 180 nre dialyzer was flushed with 2,000 ml of normal saline (ns) prior to treatment on (b)(6) 2018.Even with these precautions, the patient still experienced a rash on his neck, chest and arms; at which point the hd treatment was terminated (exact timeline unknown).The patient ¿did not want to go to the hospital on this day,¿ and returned for his next scheduled treatment on (b)(6) 2018.Additionally it was reported the exeltra 170 dialyzer had not arrived by (b)(6) 2018, thus the nephrologist ordered prednisone (dosage and route unknown) for the patient to take every treatment until the exeltra 170 dialyzer arrived.The rn reported the patient underwent hemodialysis (hd) treatments on (b)(6) 2018 without incident.The rn stated the exeltra 170 dialyzer was available for the 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 (b)(6) 2018 and the reported event of rash on the neck, chest and arms.The patient refused to be sent for evaluation in the er.While uncommon, hypersensitivity reactions are known to occur with use of optiflux dialyzer.Additionally, hypersensitivity reactions have been known to occur months, even years after use with the same dialyzer model.It was reported the patient was given prednisone prior to hd therapy on (b)(6) 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.A supplemental medwatch report will be submitted upon completion of the investigation.

Manufacturer Narrative

Plant investigation: 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: 7342770
• MDR Text Key: 102571088
• Report Number: 1713747-2018-00087
• 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: 09/03/2018
• 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; RENVELA; SERTRALINE
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Weight: 89