MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CLIC BLOOD CHAMBER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number	CL10041021
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility clinic manager (cm) reported to fresenius that a blood leak occurred at the connection between the fresenius combiset bloodlines and the crit-line clip (clic) adapter.Additional information was obtained during follow-up.The cm stated that the patient reported not feeling well approximately 1h42m after the initiation of hemodialysis (hd) treatment.The cm went to check on the patient and identified a blood leak at the connection between the clic blood chamber and the combiset bloodlines.The patient¿s estimated blood loss (ebl) was approximately 600 ml.The patient did not complete treatment that day.The patient was instructed to go to the hospital where they received 1 unit (300 ml) of blood.The patient was discharged from the hospital and not admitted.The patient appeared at the clinic the following day where they completed a full additional treatment (with a runtime of 4 hours).It was noted that the patient¿s hemoglobin at the hospital was 9 (units unknown) and their last hemoglobin count taken at the clinic prior to the event was 8.5 (units unknown).The cm noted that the patient¿s hemoglobin count is usually on the low side and they are prescribed erythropoiesis-stimulating agents (esa).Jennifer stated that the treatment was setup with a fresenius 2008t machine, a fresenius dialyzer, and fresenius bloodlines and crit-line clip (clic) adapter.The 2008t machine did not display any alarms.There were no loose connections noted within the treatment setup.There was no defect or damage noted on the bloodlines nor the clic adapter.The samples are available to be returned to the manufacturer for a physical evaluation.

• Brand Name: CLIC BLOOD CHAMBER
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 16093942
• Report Number: 3023981687-2023-00006
• Device Sequence Number: 17807254
• Product Code: KOC
• UDI-Device Identifier: 00840861100552
• UDI-Public: 00840861100552
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/04/2023
• Report Date (Section F): 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: CL10041021
• Device Catalogue Number: CL10041021
• Device Lot Number: 21LR01015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/15/2022
• Device Age: MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2023
• Date Device Manufactured: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS DIALYZER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Date Report Sent to FDA: 01/04/2023