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); Hypovolemia (2243); Blood Loss (2597)

Event Date 03/05/2018

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 a little over an hour into treatment 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.Per rn the patient had been using the fresenius optiflux 180 nr dialyzer at the time of the event.Additional follow-up was made with the rn, who stated the patient had been receiving dialysis since (b)(6) 2011 and had been using fresenius dialyzers.He received benadryl in the clinic for the symptoms and received prednisone when he went to the er via ambulance as his mouth was swollen and the clinic staff was concerned that his airway was going to swell.No additional medications had been provided in clinic.Per rn the patient was not admitted to the hospital and stated he did not receive any new medications and was sent home from the er.

Event Description

A user facility hemodialysis (hd) patient reported a little over an hour into treatment 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.Per rn the patient had been using the fresenius optiflux 180 nr dialyzer at the time of the event.Additional follow-up was made with the rn, who stated the patient had been receiving dialysis since (b)(6) 2011 and had been using fresenius dialyzers.He received benadryl in the clinic for the symptoms and received prednisone when he went to the er via ambulance as his mouth was swollen and the clinic staff was concerned that his airway was going to swell.No additional medications had been provided in clinic.Per rn the patient was not admitted to the hospital and stated he did not receive any new medications 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

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.The sub-assembly production record review was completed for the fiber bundle, o-ring, polycarbonate molded components and raw materials used in the production of the finished dialyzer lot.All materials were within acceptable parameters.Also, as part of the investigation, the reported dialyzer lot sub-assembly components were compared to the corresponding bill of materials.It was confirmed that the correct components were used during the manufacture of the dialyzer 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.

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 event(s) of rash on the face, back, chest, arms, itching and swelling of the lips which required subsequent evaluation in the er and treatment with prednisone.While uncommon, hypersensitivity reactions are known to occur with use of optiflux dialyzers (1).Additionally, hypersensitivity reactions have been known to occur months, even years after use with the same dialyzer model (2).During additional follow-up 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.However on the date of the event the patient also received iv hectorol 1,000 mcg, 19 minutes prior to the reported event(s) of facial swelling and itching; both of which are documented hypersensitivity reactions to hectorol (3).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 a user facility reported this patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) since (b)(6) 2011 experienced a suspected dialyzer allergic reaction on (b)(6) 2018.The form stated during a hd treatment, a patient experienced a rash on face, back, chest, arms, itching (severity and location unknown), and swelling of the lips/face.A follow-up e-mail was received on 03/07/2018 from a registered nurse (rn) in response to questions sent from pms.Attached to the e-mail was a medication list, an hd treatment sheet from 03/05/2018, and responses to questions sent to the rn.The e-mail stated the event(s) occurred ¿a little over an hour into treatment.¿ the patient had been utilizing an optiflux 180nre dialyzer since (b)(6) 2011.Reportedly the patient received benadryl (dosage not reported) at the outpatient dialysis clinic (dates not reported), and prednisone (dosage not reported) when he went to the emergency room (er) twice (dates not reported).The e-mail 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, the e-mail states all medication normally given to the patient during hd are being held until the patient was no longer having reactions.The hd treatment record from 03/05/2018 indicated the pre-treatment blood pressure (bp) was 134/59 sitting, and 140/73 standing, weight (w) = 91.8 kg (edw = 88.5 kg), temperature (t) = 98.1, pulse (p) = 82, respirations (r) = 18.Per the treatment record all conductivity, temperature, safety, air detector and alarms tests passed and/or were verified.The treatment was initiated at 06:21 without difficulty.At 07:16 the patient was given intravenous (iv) hectorol 1,000 mcg.At 07:35 the patient was noted to have a rash on his chest, back, face and arms.The patient denied experiencing any shortness of breath (sob), however he did complain of itching, and was given intravenous (iv) benadryl 25 mg.The patient was alert and resting comfortably until 08:07 when the patient continued to complain about itching and his face remained swollen despite the administration of benadryl.At this time the nephrologist was called, and the treatment was discontinued.The total treatment time was 1 hour and 46 min of a scheduled 4 hour hd treatment.The blood was not returned (volume unknown) and the patient was sent to the emergency room (er) via emergency medical services (ems).The hospital course and discharge disposition of the patient are unknown, however the patient was discharged the same day and returned to the outpatient dialysis clinic for their next scheduled hd treatment on (b)(6) 2018.The patient¿s vitals at the end of hd were w = 90.4, bp = 130/70 sitting, p = 68, r = 20, t = 97.9.During a follow-up call on 03/15/2018 the rn reported 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) continue to be held.

• 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: 7325740
• MDR Text Key: 101956045
• Report Number: 1713747-2018-00081
• 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,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 0500318E
• Device Lot Number: 18AU03002
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ASPIRIN; HYDROXYZINE; HYDROXYZINE; LEVOTHYROXINE; LEVOTHYROXINE; METAMUCIL; METAMUCIL; NEPRO CARB STEADY; NEPRO CARB STEADY; PREDNISONE; PREDNISONE; PROTONIX; PROTONIX; RENAPLEX; RENAPLEX; RENVELA; RENVELA; SERTRALINE; SERTRALINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 94 YR
• Patient Weight: 89