MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008T MACHINE

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 10.8 to 6.4.The patient was admitted into the hospital on (b)(6) 2019 and required a blood transfusion.The patient was discharged on (b)(6) 2019.Further details regarding the patient¿s hospitalization are currently unknown.The patient¿s hemoglobin improved to 9.9 on (b)(6) 2019.Reportedly, the patient continues to receive hemodialysis treatments.The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius 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

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

Manufacturer Narrative

Additional information: the fresenius 2008t machines were evaluated by the clinic for conductivity.The alarms limits were set at +/-.5 around tcd and the machines were adjusted to higher.Eight of the machines would not come out of bypass.The alarm set point was adjusted to the proper position.The acid loop pressure was slightly high.The loop acid pressure was adjusted and all, but two machines were within limits.An adverse event function test was performed on all machines and all machines passed.Additionally, the dialysate left in the dialyzer was checked for bleach, mincare and chlorine residue.Plant investigation: a review of the device manufacturing records was conducted by the manufacturer for machines at the facility.There were no discrepancies with temperature calibrations, conductivity checks, an blood pump arterial pressures.There was no rework performed during the production process that was related to temperature, conductivity, or the blood pump module.The device was within specification and all approved and validated processes were followed when the manufacturing process was complete.There is no evidence to conclude that the manufacturing process increased the risk of hemolysis as documented in the risk management file (rmf).In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.

• Brand Name: 2008T MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8803904
• MDR Text Key: 151501490
• Report Number: 2937457-2019-02193
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2019

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- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS CLIC BLOOD CHAMBER; FRESENIUS DIALYZER; FRESENIUS GRANUFLO ACID; FRESENIUS NATURALYTE 4000 BICARBONATE; FRESENIUS NORMAL SALINE; FRESENIUS BLOODLINES; FRESENIUS CLIC BLOOD CHAMBER; FRESENIUS DIALYZER; FRESENIUS GRANUFLO ACID; FRESENIUS NATURALYTE 4000 BICARBONATE; FRESENIUS NORMAL SALINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR