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 High Blood Pressure/ Hypertension (1908); Loss of consciousness (2418)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) clinic manager (cm) reported an hd patient arrived 15 minutes late for treatment.The patient care technician (pct) reported the patient had a high blood pressure of 255/112 and a pulse rate of 89 beats per minute (bpm).Per the pct the patient stated she forgot to take her blood pressure medication.The patient had remained asymptomatic and denied any discomfort.Clonidine 0.1 mg tablet was given to the patient orally.After 6 minutes of treatment and patient was not yet fully assessed, and the pct asked for help.The patient was unresponsive and 500cc of saline was given.The patient was then taken to the hospital.Additional follow-up was made with the clinic manager, who stated the patient was admitted to the hospital on (b)(6) 2018 due to hypertension and loss of consciousness during treatment.The cm stated the issue was discussed with the doctor, who alluded the issue was likely due to the patient not taking her heart medication prior to starting hemodialysis treatment on (b)(6) 2018.Additional follow-up was made with the cm, who stated the patient normally dialyzed using baxter exeltra dialyzer, which were not comprised of polysulfone.Per clinic manager the doctor was currently reviewing the event to determine if the patient was allergic to polysulfone.(b)(6) stated the voluntary medwatch form listed polysulfone as an allergy as it was suspected it may have also been a contributing factor to the patient¿s hospitalization event.Per clinic manager the patient used fresenius bloodlines during hemodialysis treatments.The clinic manager stated the patient was discharged and was able to return to the clinic to resume hemodialysis treatment without further issue.Per clinic manager the patient had not experienced any issues with any fresenius products in the past, and was able to continue in-center hemodialysis treatments without further issue.Medical records were requested.

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.

Event Description

Information in the complaint file and medical records (mr) were reviewed.The patient utilizing hemodialysis (hd) therapy arrived 15 minutes late for her hd treatment on (b)(6) 2018.Reportedly the patients¿ blood pressure (b/p) was 255/112 with a pulse of 89.The patient stated she forgot to take her blood pressure medications prior to arrival.However, the patient was reported as asymptomatic and denied any discomfort.The patient was administered clonidine 0.1 mg tablet per oral (po).Hd treatment on the fresenius 2008t machine utilizing fresenius combi set blood lines and optiflux 180nre dialyzer and the following concentration 2k, 2.5 ca, 1 mag, 100 dextrose and a 1000 ml of normal saline was initiated.2008t machine settings are not known.Six minutes after the initiation of hd treatment the patient was noted to be unresponsive.Saline 500ml was administered; no other information related to the patient assessment was provided.Paramedics were summoned to the scene and the patient was transported to the hospital; no medical intervention prior to or during transport was known.Per mr the patient presented to the emergency room (er) with malignant hypertension with a brief syncope episode and acute encephalopathy.The patient regained consciousness and complained of a headache and chest pain, and the patient oriented to name only; the patient was lethargic, confused and slow to respond.In the er the patient was hypertensive with a blood pressure (b/p) of 239/66.A computerized tomography (ct) of the brain was performed; no bleed.Chest x-ray (cxr) - unchanged cardiomegaly and central vascular congestion, no pleural effusion or pneumothorax.The patient was admitted to the hospital on (b)(6) 2018 for treatment of hypertensive emergency/urgency and acute encephalopathy.The patients¿ encephalopathy remained despite lowering of patients¿ b/p with dialysis and antihypertensive.The mri did not show any acute event or stroke.The possibility of seizure, electroencephalogram (eeg) was done, which revealed left frontal periodic lateralized epileptiform discharges, which was nonspecific, but seizure not ruled out.Neurology was consulted, who favored more toxic metabolic encephalopathy over seizure; the patient had received morphine and ativan in the er.The patient was started on keppra and after hd treatment of 7 and 8 the patients mentation improved.The patients¿ hospitalization was complicated by an episode of vomiting x 2 during hd treatment 3.The patient was treated prophylactically for aspiration pneumonia; although chest x-ray was clear, but procalcitonin level was elevated to 2.56 and the white blood cell count of 20.The patient complained of chest pain, and was relieved with a gastrointestinal cocktail.During the hospitalization the patients¿ vital signs range: b/p systolic 175 ¿ 252, diastolic 48 - 66, pulse (p) 88, respiratory rate (rr) 18.The patient was discharge to a short-term nursing facility (b)(6) 2018 where a full recovery was expected.During a follow-up call to the clinic manager on 02/21/2018 it was felt the patient not taking her b/p medications prior to the hd treatment on (b)(6) 2018 was the cause for the episode and related hospitalization.The clinic manager also stated the patient has not experienced any issues with any fresenius products in the past.The clinic manager revealed on 03/01/2018 the baxter exeltra dialyzer was what the patient ¿normally¿ uses for hd therapy.Information obtained in the medwatch listed ¿polysulfone¿ as an allergy.The fresenius optiflux 180nre dialyzer contained polysulfone polymer in the membrane material.The mr review revealed the patient had been seen in the hospital for a previous for a syncopal episode in the setting of dialysis.It appeared the patient had been previously admitted for a dialyzer reaction and an order to use baxter dialyzers only.The dialysis unit used a regular dialyzer (optiflux 180nre) as they ran out of baxter dialyzers.

Manufacturer Narrative

A temporal association between the 2008k machine, combi set blood lines and optiflux 180nre dialyzer and the following concentration 2k, 2.5 ca, 1 mag, 100 dextrose and the adverse event of the patient becoming unresponsive leading to a subsequent hospitalization exist.However, it is documented that the patient had an allergy to polysulfone which is a component of the membrane material of the optiflux 180nre dialyzer.It was further identified in the mr that the patient had previous for a syncopal episode (unknown date) in the setting of hd treatment and was previously admitted (date unknown) to the hospital for a dialyzer reaction and ordered to use baxter dialyzers only.It is most probable that this syncope episode was the result of the patient being dialyzed with the optiflux 180nre dialyzer for which an allergy (dialyzer reaction) had previously been established instead of the ordered baxter dialyzer.The coinciding hypertensive episode was most likely part of the patients¿ co-morbid conditions that she was receiving medical treatment for.Additionally, it was reported the patient neglected to take her blood pressure medications prior to hd treatment on (b)(6) 2018.It was not determined if the acute encephalopathy episode was the result of seizure activity or medically induced from the narcotics and benzos the patient received in the er.However, keppra was ordered and during the time frame of hd 7-8 the patient mentation improved and was getting closer to baseline.A supplemental medwatch report will be submitted upon completion of the investigation.

Manufacturer Narrative

Conclusion: a temporal association between the 2008k machine, combi set blood lines and optiflux 180nre dialyzer and the following concentration 2k, 2.5 ca, 1 mag, 100 dextrose and the adverse event of the patient becoming unresponsive leading to a subsequent hospitalization exist.Additionally, there is documentation to suggest that the patient may have had an allergy to polysulfone which is a component of the membrane material of the optiflux 180nre dialyzer.However, it was reported by the clinic manager that after a discussion with the patients' physician the probable cause may have been related to the patient omitting b/p medications prior to the hd treatment performed on (b)(6) 2018.Although the hospital course is unknown the patient has since returned to the outpatient clinic and resumed hd treatments without further incidence.Potential causality has not been established.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Information in the complaint file which included a medwatch completed by a user facility received on 02/19/2018 was reviewed by a post market surveillance clinician.It was reported that this end stage renal disease (esrd) patient utilizing hemodialysis (hd) therapy for renal replacement therapy arrived 15 minutes late for her hd treatment on (b)(6) 2018.Reportedly the patients¿ blood pressure (b/p) was 255/112 with a pulse of 89.The patient stated she forgot to take her blood pressure medications prior to arrival.However, the patient was reported as asymptomatic and denied any discomfort.The patient was administered clonidine 0.1 mg tablet per oral (po).At an unknown time, hd treatment on the fresenius 2008t machine utilizing fresenius combi set blood lines and optiflux 180nre dialyzer and the following concentration 2k, 2.5 ca, 1 mag, 100 dextrose and a 1000 ml of normal saline was initiated.2008t machine settings are not known.Reportedly, 6 minutes after the initiation of hd treatment the patient was noted to be unresponsive.Saline 500ml was administered; no other information related to the patient assessment was provided.Paramedics were summoned to the scene and the patient was transported to the hospital; no medical intervention prior to or during transport was known.During a follow-up call to the clinic manager (hd outpatient clinic) on 02/21/2018 it was learned that the patient was admitted to the hospital on (b)(6) 2018 due to hypertension and loss of consciousness during treatment.The hospital course is unknown.The clinic manager stated the after a discussion with the patients¿ doctor it was felt the patient not taking her b/p medications prior to the hd treatment on (b)(6) 2018 was the cause for the episode and related hospitalization.The patient was discharged on an unknown date and returned to the hd outpatient clinic on (b)(6) 2018 for a hd treatment which was completed without any adverse events.The clinic manager also stated the patient has not experienced any issues with any fresenius products in the past.During a follow up call on 03/01/2018 to the clinic manager (cm) it was learned that the baxter exeltra dialyzer is what the patient ¿normally¿ uses for hd therapy.It was unknown why the patient was dialyzed on (b)(6) 2018 with the fresenius optiflux 180nre dialyzer.The information obtained in the medwatch listed ¿polysulfone¿ as an allergy.It was reported that the patients hd treatment on (b)(6) 2018 involved the use of the fresenius optiflux 180nre dialyzer which contained polysulfone polymer in the membrane material.The cm stated at the time the patient¿s physician was in the process of determining if the patient was allergic to the polysulfone and to what if any extent it played in the patient¿s adverse event and hospitalization.

• 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: 7309612
• MDR Text Key: 101378548
• Report Number: 1713747-2018-00070
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 0500318E
• Device Lot Number: 17SU03011
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS OPTIFLUX 180NRE DIALYZER; FRESENIUS BLOODLINES; FRESENIUS OPTIFLUX 180NRE DIALYZER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 61