MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500316E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Reaction (2414); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between hd therapy utilizing the optiflux 160nre dialyzer and the adverse event(s) of dyspnea, diaphoresis, anaphylaxis, loss of consciousness, cardiac arrest, and death.While the etiology of event(s) was felt to be a dialyzer reaction, the specific cause of death unknown; therefore, causality cannot be firmly established.While uncommon, hypersensitivity reactions are known to occur with use of optiflux dialyzers.Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.Based on the information available, the optiflux 160nre dialyzer cannot be disassociated from the event(s).The dialyzer was discarded and is unavailable for manufacturer investigation.Additionally, given the events occurred during hd therapy while utilizing the product, a possible causal or contributory role cannot be ruled out.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a patient on home hemodialysis (hd) for renal replacement therapy (rrt) 4 days a week became unresponsive during hd therapy at an outpatient clinic.The patient was undergoing hd therapy for 13 min when the patient began coughing, became short of breath and diaphoretic.A physician evaluated the patient, and no breath sounds were noted.911 was called and the patient was transported to the hospital.Follow-up with the clinical manager revealed the patient came to the outpatient dialysis clinic for a single back-up hemodialysis (hd) treatment, because their home nxstage machine was being replaced (details not provided).The clinical manager reported during hd therapy the patient experienced a severe dialyzer reaction, and became dyspneic, diaphoretic and stopped breathing.The patient reportedly expired approximately one week later in the hospital.The discharge summary was received, which stated the patient had an anaphylactic reaction and coded.The summary states emergency medical services (ems) arrived, resuscitated and intubated the patient, and transported him to the emergency department (ed).Cardiopulmonary resuscitative (cpr) measures were continued until the patient had a return of spontaneous circulation (rosc).The patient¿s arterial blood gas showed a ph of 6.9, and a chest x-ray showed pulmonary edema (details not provided).The patient was started on intravenous (iv) epinephrine (dosage not provided) delivered through a right intra jugular (ij) central line.The patient¿s potassium was 6.9 (value not provided) and the patient was given insulin, dextrose, albuterol and calcium.The patient was sedated with propofol and transferred to the intensive care unit (icu) for dialysis.The patient expired seven days later.The document indicates the patient remained in the icu; unresponsive, intubated and requiring a ventilator to breathe until his death.The patient underwent two electroencephalography (eeg) scans (dates not provided) which showed no improvement and were concerning for anoxic brain injury.The patient underwent a chest x-ray (dates not provided) after experiencing fevers (value not provided) and leukocytosis (values not provided), which showed an infiltrated right middle lobe.The patient was treated with vancomycin and zosyn, however the dosages, routes and frequencies not provided.The patient underwent hd while hospitalized, and experienced foaming at the mouth and was hypotensive (dates not provided).Given the patient¿s recent medical history, and concern for anaphylaxis, the nephrologist switched out the dialyzer (type not provided) as a precaution.However, after the change was made, it was felt the hypotension and foaming at the mouth was not likely related to the dialyzer.The patient¿s prognosis was documented as poor, and a palliative care meeting was held with the family.Two days later, the patient became pulseless, a partial code (details not provided) was called, and the patient received ¿pressors¿ (specifics not provided).The patient¿s spouse elected to terminate efforts at resuscitation after two vasopressors could not generate a sustained perfusing heart rhythm.

Manufacturer Narrative

Plant investigation: 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.An investigation of the device history records (dhr) was conducted by the manufacturer.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 reported lot number passed pyrogen testing, was within sterilization dosage parameters.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.

• Brand Name: OPTIFLUX 160NRE 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: 8690900
• MDR Text Key: 147727562
• Report Number: 1713747-2019-00180
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• 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
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 0500316E
• Device Lot Number: 19AU06007
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 92