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	10/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: 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 a blood leakage from a crit-line blood chamber that occurred during a patient treatment.The rn reported the crit-line blood chamber exhibited a blood leakage from the seam where the crit-line clic connects.As a result, the treatment was halted, the blood was returned to the patient, and an entirely new setup was implemented, allowing the treatment to continue without any further incidents.The compromised blood chamber was not saved and was disposed of.Upon follow-up, the clinic manager (cm) stated on (b)(6) 2025 immediately after initiation of the patient's hemodialysis (hd) treatment, a blood leak was observed from the seam where the crit-line clic connects.Treatment was paused and the patient¿s blood was successfully returned.Per cm the patient¿s estimated blood loss (ebl) was minimal and did not provide a quantitative volume.The cm noted that the patient remained asymptomatic and confirmed that the patient did not experience a serious injury or require medical intervention as a result of this issue.The machine, a 2008t, was not expected to and did not alarm.The patient was utilizing fresenius bloodlines.No damage was noted on the crit-line blood chamber prior to treatment.Immediately following the event, the patient was re-setup with new supplies on the same machine and completed treatment without further issue.The machine has remained in service.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The sample was discarded and was no longer available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.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.
Event or Problem Description
A user facility registered nurse (rn) reported a blood leakage from a crit-line blood chamber that occurred during a patient treatment.The rn reported the crit-line blood chamber exhibited a blood leakage from the seam where the crit-line clic connects.As a result, the treatment was halted, the blood was returned to the patient, and an entirely new setup was implemented, allowing the treatment to continue without any further incidents.The compromised blood chamber was not saved and was disposed of.Upon follow-up, the clinic manager (cm) stated on (b)(6) 2025 immediately after initiation of the patient's hemodialysis (hd) treatment, a blood leak was observed from the seam where the crit-line clic connects.Treatment was paused and the patient¿s blood was successfully returned.Per cm the patient¿s estimated blood loss (ebl) was minimal and did not provide a quantitative volume.The cm noted that the patient remained asymptomatic and confirmed that the patient did not experience a serious injury or require medical intervention as a result of this issue.The machine, a 2008t, was not expected to and did not alarm.The patient was utilizing fresenius bloodlines.No damage was noted on the crit-line blood chamber prior to treatment.Immediately following the event, the patient was re-setup with new supplies on the same machine and completed treatment without further issue.The machine has remained in service.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The sample was discarded and was no longer available to be returned for manufacturer 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
• 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: 23250573
• Report Number: 0008030665-2025-02407
• Device Sequence Number: 10425655
• Product Code: KOC
• UDI-Device Identifier: 00840861100552
• UDI-Public: 00840861100552
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: CL10041021
• Device Lot Number: 23JR01183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Sex: Unknown