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

Catalog Number	CL10041021
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility registered nurse (rn) reported that the crit-line clip (clic) blood chamber leaked during a patient's hemodialysis (hd) treatment.Additional information was obtained during follow-up with the rn.The reported event was identified approximately 20 minutes after treatment initiation when blood was visually observed dripping from the blood chamber.The rn could not state whether any defect or damage was noted to the blood chamber.There were no loose connections or issues identified during prime.The patient did not experience a serious injury or require medical intervention.The patient's estimated blood loss (ebl) was approximately 300 ml.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility registered nurse (rn) reported that the crit-line clip (clic) blood chamber leaked during a patient's hemodialysis (hd) treatment.Additional information was obtained during follow-up with the rn.The reported event was identified approximately 20 minutes after treatment initiation when blood was visually observed dripping from the blood chamber.The rn could not state whether any defect or damage was noted to the blood chamber.There were no loose connections or issues identified during prime.The patient did not experience a serious injury or require medical intervention.The patient's estimated blood loss (ebl) was approximately 300 ml.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the manufacturer received a sample for physical evaluation.The sample was received open without its original packaging.No leaks were detected as the complaint product sample was being disinfected and prepared for analysis.During visual inspection with the microscope a bad welding was identified on the clic lens.The complaint product was functionally tested with a 2008k machine and a leak was found on the side of the clic.After further inspection, no other problems were found.The reported issue was confirmed through phyiscal evaluation of the returned sample.A device history record (dhr) review was performed for the involved lot of the product and there were no non-conformances or any associated rework related with the alleged failure mode during the assembly process of the lot involved.All the applicable in-process and final inspection tests were found with acceptable results.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18130291
• Report Number: 0008030665-2023-01037
• Device Sequence Number: 15110231
• Product Code: KOC
• UDI-Device Identifier: 00840861100552
• UDI-Public: 00840861100552
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CL10041021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Sex: Male