MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number UNKNOWN- FMC BLOODLINE

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

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.In addition, there are no product malfunction reported, with the information available, it is not possible to determine a causal relationship between the product and the incident.

• Brand Name: FMC BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 8804457
• MDR Text Key: 151501172
• Report Number: 8030665-2019-01095
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• 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: 09/05/2019

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- FMC BLOODLINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2008T MACHINE; FRESENIUS CLIC BLOOD CHAMBER; FRESENIUS DIALYZER; FRESENIUS GRANUFLO ACID; FRESENIUS NATURALYTE 4000 BICARBONATE; FRESENIUS NORMAL SALINE; 2008T MACHINE; FRESENIUS CLIC BLOOD CHAMBER; FRESENIUS DIALYZER; FRESENIUS GRANUFLO ACID; FRESENIUS NATURALYTE 4000 BICARBONATE; FRESENIUS NORMAL SALINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR