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

Catalog Number	03-2722-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/28/2025
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 nurse manager (nm) reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.The combi set reportedly ¿split in two¿.The patient¿s blood could not be returned.Additional details were provided upon follow-up with the nm.With two hours and six minutes remaining in the treatment, an air detector alarm went off.The staff inspected the lines and noticed a small amount of blood leaking from the combi set between the arterial line and blood pump.No further explanation was provided on what was meant by ¿split in two¿.The nm confirmed the combi set was inspected for damage prior to use, and that no damage or defect was noted at that time.Nothing noteworthy occurred during the prime.There were no changes or disruptions in pressure that could have contributed to the leak.There were no loose connections noted on the combi set lines.The patient's estimated blood loss (ebl) due to the event was 200ml.Following the leak, the patient had their hemoglobin checked.The patient was re-setup with new supplies and completed their treatment on the same machine.The patient tolerated the treatment well, and agreed to have their hemoglobin rechecked.The patient did not experience any adverse effects or require any medical intervention due to the blood loss.The sample was confirmed to be available to be sent back for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: during the visual inspection with a microscope, it was found that the tubing had a presence of solvent, however, there was a delamination from the wall of the saline line tubing to the wall of the saline ¿t¿ connector.No other issues were found in the remaining components of the returned sample.
Event or Problem Description
A user facility nurse manager (nm) reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.The combi set reportedly ¿split in two¿.The patient¿s blood could not be returned.Additional details were provided upon follow-up with the nm.With two hours and six minutes remaining in the treatment, an air detector alarm went off.The staff inspected the lines and noticed a small amount of blood leaking from the combi set between the arterial line and blood pump.No further explanation was provided on what was meant by ¿split in two¿.The nm confirmed the combi set was inspected for damage prior to use, and that no damage or defect was noted at that time.Nothing noteworthy occurred during the prime.There were no changes or disruptions in pressure that could have contributed to the leak.There were no loose connections noted on the combi set lines.The patient's estimated blood loss (ebl) due to the event was 200ml.Following the leak, the patient had their hemoglobin checked.The patient was re-setup with new supplies and completed their treatment on the same machine.The patient tolerated the treatment well, and agreed to have their hemoglobin rechecked.The patient did not experience any adverse effects or require any medical intervention due to the blood loss.The sample was confirmed to be available to be sent back for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint sample was returned to the manufacturer for physical evaluation.The sample was received without its original packaging.As the sample was being disinfected and prepared for analysis, a leak was found on the assembly from the main line to the pump ¿t¿ connector.The main line separated from the pump ¿t¿ connector during the disinfection.A visual inspection under a microscope was performed on the assembly of the main line to the pump ¿t¿ connector.The inspection showed that solvent was not properly applied on the tube, solvent reside was on one side of the tube (away from the assembly area), and no solvent was found on the tip of the tube inside the red ¿t¿ connector¿s port.No other problems or abnormalities were identified during the evaluation.The observed defect may be attributed to improper assembly during the manufacturing process, with several potential contributing factors.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.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.Based on the sample evaluation, the reported issue was able to be confirmed.
Event or Problem Description
A user facility nurse manager (nm) reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.The combi set reportedly ¿split in two¿.The patient¿s blood could not be returned.Additional details were provided upon follow-up with the nm.With two hours and six minutes remaining in the treatment, an air detector alarm went off.The staff inspected the lines and noticed a small amount of blood leaking from the combi set between the arterial line and blood pump.No further explanation was provided on what was meant by ¿split in two¿.The nm confirmed the combi set was inspected for damage prior to use, and that no damage or defect was noted at that time.Nothing noteworthy occurred during the prime.There were no changes or disruptions in pressure that could have contributed to the leak.There were no loose connections noted on the combi set lines.The patient's estimated blood loss (ebl) due to the event was 200ml.Following the leak, the patient had their hemoglobin checked.The patient was re-setup with new supplies and completed their treatment on the same machine.The patient tolerated the treatment well, and agreed to have their hemoglobin rechecked.The patient did not experience any adverse effects or require any medical intervention due to the blood loss.The sample was confirmed to be available to be sent back for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: d9, h4.The plant investigation is still in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility nurse manager (nm) reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.The combi set reportedly ¿split in two¿.The patient¿s blood could not be returned.Additional details were provided upon follow-up with the nm.With two hours and six minutes remaining in the treatment, an air detector alarm went off.The staff inspected the lines and noticed a small amount of blood leaking from the combi set between the arterial line and blood pump.No further explanation was provided on what was meant by ¿split in two¿.The nm confirmed the combi set was inspected for damage prior to use, and that no damage or defect was noted at that time.Nothing noteworthy occurred during the prime.There were no changes or disruptions in pressure that could have contributed to the leak.There were no loose connections noted on the combi set lines.The patient's estimated blood loss (ebl) due to the event was 200ml.Following the leak, the patient had their hemoglobin checked.The patient was re-setup with new supplies and completed their treatment on the same machine.The patient tolerated the treatment well, and agreed to have their hemoglobin rechecked.The patient did not experience any adverse effects or require any medical intervention due to the blood loss.The sample was confirmed to be available to be sent back for manufacturer evaluation.

• Brand Name: CUSTOM COMBI SET
• Common Device Name: 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
• 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: 23183795
• Report Number: 0008030665-2025-02323
• Device Sequence Number: 9815591
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2026

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 Catalogue Number: 03-2722-9
• Device Lot Number: 25JR01111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 03/03/2026; 03/19/2026; 03/19/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 03/09/2026; 03/25/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 90 KG