MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- DIALYZER

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¿s pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen.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 from 8.9 to 7.2.The patient was admitted into the hospital on (b)(6) 2019 with a hemoglobin of 5.9 and positive schistocytes.The patient required a blood transfusion.The patient was discharged on (b)(6) 2019.Further details regarding the patient¿s hospitalization are currently unknown.Reportedly, the patient continues to receive hemodialysis treatments.The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius 160 and 180 dialyzers, fresenius granuflo acid (2551) 2.0 potassium/2.5 calcium, fresenius naturalyte 4000 bicarbonate, fresenius clic blood chamber and fresenius normal saline.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

Additional information: concomitant medical products, device evaluated by mfr plant investigation: although it was reported actual samples for the patient's treatments were available, no samples were returned with patient identifiers for the current event.12 companion dialyzers, three from each of these lot numbers 19bu03011, (b)(6)2007, 19cu06021, and 19cu04001 for the investigation.There was no visual indication of any defect or irregularity of any type on the dialyzers.The companion samples were forwarded to the qs laboratory for ultrafiltration, bubble point, and sodium clearance testing.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.A lot history review was performed for each of the four investigated lot numbers.Lot number 19bu03011 had 8 complaints, (b)(6)2007 had 1 complaint, 19cu06021had 2 complaints, and 19cu04001 had 4 complaints.There are no complaints of any type from any other customers.The production record was reviewed for each of the four lot numbers 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 lot numbers passed pyrogen testing, were within sterilization dosage parameters, and passed all release criteria.During the investigation there were was no indication of a product deficiency or relationship to the report of hemolysis.

• Brand Name: DIALYZER
• 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: 8804524
• MDR Text Key: 151502718
• Report Number: 1713747-2019-00220
• Device Sequence Number: 1
• Product Code: KDI
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- DIALYZER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Device Age: MO
• Date Manufacturer Received: 10/23/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 30 YR