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	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A registered nurse (rn) reported to fresenius that a clic blood chamber leaked within the first five minutes of a patient¿s hemodialysis (hd) treatment.It was noted that blood was dripping onto the floor.The rn said that only a few drops of blood had leaked out.The leak was coming from the crit-line blood chamber, at the glued connection just below the blood chamber body.The rn said there were also high venous pressure alarms.Upon follow-up with the rn it was reported that this patient uses small bloodlines, and therefore it was not unusual to see elevated venous pressures in the system.Air was not suspected to have entered the circuit, and there were no alarms to indicate so.The blood was cleaned up, and the treatment was continued.However, blood continued to drip outside of the chamber.When it was noted that the leaking had continued, the treatment was stopped and the patient¿s blood was returned.There was no visible damage noted at the leak location.Additionally, there were no issues noted during the prime.Estimated blood loss (ebl) due to the leak was minimal.The rn estimated patient blood loss to be 2ml.As a precaution, the patient was given prophylactic antibiotics.The rn confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete their treatment on the same machine after being re-setup with new supplies.A photo was provided (not of the actual device) to illustrate where the leak was coming from.The sample was not available to be returned for evaluation as it was reportedly discarded.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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 registered nurse (rn) reported to fresenius that a clic blood chamber leaked within the first five minutes of a patient¿s hemodialysis (hd) treatment.It was noted that blood was dripping onto the floor.The rn said that only a few drops of blood had leaked out.The leak was coming from the crit-line blood chamber, at the glued connection just below the blood chamber body.The rn said there were also high venous pressure alarms.Upon follow-up with the rn it was reported that this patient uses small bloodlines, and therefore it was not unusual to see elevated venous pressures in the system.Air was not suspected to have entered the circuit, and there were no alarms to indicate so.The blood was cleaned up, and the treatment was continued.However, blood continued to drip outside of the chamber.When it was noted that the leaking had continued, the treatment was stopped and the patient¿s blood was returned.There was no visible damage noted at the leak location.Additionally, there were no issues noted during the prime.Estimated blood loss (ebl) due to the leak was minimal.The rn estimated patient blood loss to be 2ml.As a precaution, the patient was given prophylactic antibiotics.The rn confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete their treatment on the same machine after being re-setup with new supplies.A photo was provided (not of the actual device) to illustrate where the leak was coming from.The sample was not available to be returned for evaluation as it was reportedly discarded.

• 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: 24635176
• Report Number: 0008030665-2026-00532
• Device Sequence Number: 8953448
• Product Code: KOC
• UDI-Device Identifier: 00840861100552
• UDI-Public: 00840861100552
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/13/2026

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: 06/30/2026
• Device Catalogue Number: CL10041021
• Device Lot Number: 23HR01226
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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.
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 31 KG