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 Cardiopulmonary Arrest (1765); Reaction (2414); Loss of consciousness (2418)

Event Date 01/22/2018

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 loss of consciousness and cardiopulmonary arrest 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 10 minutes into the patient¿s hemodialysis (hd) treatment.At this time, the patient became unresponsive.No pulse was found and the patient was not breathing.Hd treatment was stopped and all blood returned to the patient.Cardiopulmonary resuscitation (cpr) was initiated and oxygen was given via artificial manual breathing unit (ambu) bag with 15l of o2 given.The automated external defibrillator (aed) was applied and no shock was advised.The patient¿s blood pressure (bp) was recorded as 103/37 and the aed advised to continue cpr.The aed then advised to stop cpr, bp was recorded as 51/25, and no shock was advised.The aed advised to continue cpr, and after four rounds of cpr the patient began responding.Cpr was stopped.The patient was alert and transported to the hospital via emergency medical services (ems) at with a bp of 55/36 and heart rate (hr) of 88.Per the clinic manager, the patient was subsequently hospitalized (exact dates unknown), and additional details regarding the patient¿s hospital course are unknown as the discharge paperwork is not available.The clinic manager stated 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.The lot number of the complaint dialyzer was not provided.The complaint sample is not available as it was discarded at the facility.As no lot number was provided for this complaint, a search was performed to obtain all lot numbers delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.A total of seventeen lot numbers were found to be delivered to the customer 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.Five lots had two approved temporary deviation notices (dn) on each and twelve lots had a single approved temporary deviation notice (dn) on each.They are all 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 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.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 7287154
• MDR Text Key: 100617590
• Report Number: 1713747-2018-00061
• 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: 06/04/2018

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: 05/23/2018
• 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