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 Syncope (1610); Cardiopulmonary Arrest (1765); High Blood Pressure/ Hypertension (1908); Nausea (1970); Reaction (2414); Loss of consciousness (2418)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a clinical investigation was performed to identify a causal relationship between the hemodialysis (hd) treatment and the adverse event reported.Based on the provided information, there is a temporal relationship between the patient event of nausea, loss of consciousness and subsequent hospitalization and the fresenius optiflux 180nre dialyzer.In rare cases, persons with hypersensitivity to the polysulphone membranes and/or e-beam sterilization are at risk for anaphylactic or anaphylactoid reactions.Hypersensitivity reactions may cause mild to severe signs and symptoms, including: itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest.

Event Description

A user facility clinic manager reported a dialyzer reaction that occurred approximately 13 minutes into the patient¿s hemodialysis (hd) treatment.At this time, the patient became unresponsive.A sternal rub was given with no response and cardiopulmonary resuscitation (cpr) was initiated.After 15 compressions, the patient responded, and cpr was stopped.Emergency medical services (ems) arrived and transported the patient to the emergency room (er).Per the information in the discharge summary, the patient reported being nauseous prior to treatment and arrival at the clinic, and took a pill (type, dose, and strength unknown) for the nausea.The patient stated feeling nauseated during hd treatment, and recalls a feeling of blackness and passing out.The patient stated remembering the compressions.Per ems, the patient never lost a pulse.The patient was admitted for further evaluation and placed on telemetry monitoring which did not result in any significant arrhythmias.The patient underwent magnetic resonance imaging (mri) of the brain with no acute findings.The patient¿s dose of procardia was increased (dose unknown) due to uncontrolled hypertension.The patient is non-compliant with medication and was given extensive counseling regarding medication compliance.An echocardiogram (echo) was ordered, but the patient insisted on being discharged before the echo was completed.The patient did not experience any recurrence of the symptoms during hospitalization.The patient was discharged to home on (b)(6) 2018 tolerating ambulation without any orthostatic symptoms.Per the clinic manager, the patient was new to in-center hd treatments and previously completed home hd treatments with no issues.The clinic manager stated that the patient has returned to home hd treatments with no reported issues.The clinic manager suspected that the patient had a dialyzer reaction to the optiflux 180nre dialyzer.The clinic manager stated that the patient was changed to a new dialyzer, however, it is unknown what dialyzer the patient was transitioned to for home treatments.The lot number of the complaint device was unavailable.The clinic manager confirmed that the complaint device was discarded and is not available to be returned to the manufacturer for evaluation.

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.Fourteen 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 (dn) reported on two of the lots which were unrelated to the complaint event.There was one approved dn on the remaining twelve lots which was 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: 7286956
• MDR Text Key: 100608789
• Report Number: 1713747-2018-00060
• 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
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• 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: DEXTROSE (100); FRESENIUS 2008T MACHINE; FRESENIUS COMBISET BLOODLINES; GRANUFLO (G2231) 2K; NORMAL SALINE (1000ML); DEXTROSE (100); FRESENIUS 2008T MACHINE; FRESENIUS COMBISET BLOODLINES; GRANUFLO (G2231) 2K; NORMAL SALINE (1000ML)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 89