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 Problem Hemolysis (1886)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between the hemodialysis treatments performed on (b)(6) 2019 using the 2008 t hemodialysis machine, fresenius bloodlines, fresenius dialyzers, granuflo acid, naturalyte 4000 bicarbonate, fresenius clic blood chamber and the patient¿s hemolysis event requiring hospital admission for blood transfusion.The clinic investigation has not successfully identified the source of the hemolysis.There is no objective evidence of any user error, non-compliance to standard operating procedure, chemical/toxic exposures, or any thermal/mechanical causes.The manufacturer¿s product analysis is pending at the time of this clinical investigation.Therefore, any concomitant fresenius products utilized cannot be excluded as a possible causal or contributory factor in the event.There have been no reported defects with any fresenius products used in relation to this event.There have not been any new reports of any additional hemolysis cases associated with use of fresenius products.The granuflo mix and bicarbonate mix tested had a normal specific gravity according to documentation on clinic logs.Moreover, it was reported there were no conductivity alarms on the 2008 t machines.Electrolyte panels of the final dialysate were also within normal limits.The patient sodium levels were normal.It appears unlikely an osmolar insult from the acid or bicarbonate occurred.The patients were not using the same size or lot of optiflux dialyzers which suggests the dialyzers did not cause the hemolysis event due to the degree of variability.There were no reported blood leaks or defects with any of the optiflux dialyzers used.All 2008 t machines passed pre-treatment and post -event functionality testing.There were no unexpected machine alarms in relation to the event.The cause of the hemolysis cannot be determined.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

An area technical operations manager (atom) reported that a hemodialysis patient experienced hemolysis event.Upon follow up, the hemolysis event appears to have occurred between (b)(6) 2019.The patient was not dialyzing in the clinic on (b)(6) 2019 and (b)(6) 2019 because the patient was in the hospital due to a planned lower extremity amputation (not related to hemodialysis or any fresenius products).The patient¿s pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen.The patient¿s hemoglobin was 10.2 on (b)(6) 2019.The patient was reported dialyzing on (b)(6) 2019 and (b)(6) 2019 with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius 180 dialyzers, fresenius granuflo acid (2551) 2.0 potassium/2.5 calcium, fresenius naturalyte 4000 bicarbonate, fresenius clic blood chamber and fresenius normal saline.On (b)(6) 2019, the clinic manager reviewed the lab results which were drawn post hemodialysis treatment and noticed the patient had a drop in their baseline hemoglobin to 8.8.The patient required a blood transfusion on (b)(6) 2019; however, they were not admitted to the hospital.The patient¿s hemoglobin increased to 10.It was reported there were no visual defects or anything unexpected with any of the fresenius products used, as well as no machine alarms, clotting events and/or dialyzer leaks in relation to the hemolysis event.It was reported there was nothing unusual in any of the hemodialysis treatments.There were no visible signs of hemolysis during any treatment such as, translucent/cherry colored blood, which is typical with hemolysis in hemodialysis or any patient symptoms.The patient completed all their hemodialysis treatments during the timeframe without any adverse effect.Currently, the cause of the hemolysis event is unknown.The actual and companion samples of the fresenius products used between (b)(6) 2019 have been sent to the manufacturer for further investigation.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.During the gross visual examination of the samples, the actual sample had blood throughout the dialyzer and coagulated blood present within each header.The companion samples were returned sealed within the prepackaging pouch with no damage or irregularity.There was no visual indication of any defect or irregularity of any type on any of the dialyzers.The companion samples were forwarded to the qs laboratory for ultrafiltration, bubble point, and sodium.The qs dialyzer laboratory performance test (bubble point, sodium clearance and ultrafiltration) results did not identify any defects or irregularities on any of the dialyzers.The dye solution from sodium clearance was visible and uniform throughout the fiber bundle of the tested dialyzers.The ultrafiltration test results indicated that each dialyzer performed within acceptable parameters.There was no indication of product performance deficiency or a leak observed during bubble point testing.The production record was reviewed and there was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.During the investigation of lot number 19bu03011, there were was no indication of a product deficiency or relationship to the report of hemolysis in patients at fms louisa.Review of the production record, as well as the performance testing of the companion samples, demonstrated that the dialyzers met all specifications and requirements for release.No other complaints related to hemolysis or any complaint issue have been received from any other customers on this lot number.

• 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: 8806688
• MDR Text Key: 151587319
• Report Number: 1713747-2019-00224
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 0500318E
• Device Lot Number: 19BU03011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Device Age: MO
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS CLIC BLOOD CHAMBER; FRESENIUS GRANUFLO ACID; FRESENIUS NATURALYTE 4000 BICARBONATE; FRESENIUS NORMAL SALINE; 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS CLIC BLOOD CHAMBER; FRESENIUS GRANUFLO ACID; FRESENIUS NATURALYTE 4000 BICARBONATE; FRESENIUS NORMAL SALINE
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR