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

Catalog Number	03-2622-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/25/2025
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
The facility administrator (fa) from a hemodialysis (hd) user facility reported that a combi set blood leak occurred during a patient¿s hd treatment.The machine, a fresenius 2008t system, alarmed with an air detector message approximately fifteen minutes into the treatment.The technician operating the machine noticed air present in the dialyzer and lines, and saw blood dripping from an unspecified location on the arterial line.The fa confirmed there were no lines that disconnected.The technician stopped the blood pump after observing the leak, and the patient was disconnected from the set up.The patient¿s blood was not returned.The fa said they have been using the bloodlines which require them to screw on the saline line, and the fa thinks the technician may have misthreaded the line causing a leak at the connection point.Conversely, the technician believes there was a hole in the arterial line.The fa did not see any visible damage on the line and could not corroborate the allegation of a hole.There were no leaks during the prime, and there were no known changes in pressure that could have contributed to the leak.The patient¿s estimated blood loss (ebl) was 300 ml.The fa confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The complaint device was discarded and therefore unavailable to be sent back to the manufacturer for evaluation.
Event or Problem Description
The facility administrator (fa) from a hemodialysis (hd) user facility reported that a combi set blood leak occurred during a patient¿s hd treatment.The machine, a fresenius 2008t system, alarmed with an air detector message approximately fifteen minutes into the treatment.The technician operating the machine noticed air present in the dialyzer and lines, and saw blood dripping from an unspecified location on the arterial line.The fa confirmed there were no lines that disconnected.The technician stopped the blood pump after observing the leak, and the patient was disconnected from the set up.The patient¿s blood was not returned.The fa said they have been using the bloodlines which require them to screw on the saline line, and the fa thinks the technician may have misthreaded the line causing a leak at the connection point.Conversely, the technician believes there was a hole in the arterial line.The fa did not see any visible damage on the line and could not corroborate the allegation of a hole.There were no leaks during the prime, and there were no known changes in pressure that could have contributed to the leak.The patient¿s estimated blood loss (ebl) was 300 ml.The fa confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The complaint device was discarded and therefore unavailable to be sent back to the manufacturer for 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.

• Brand Name: 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: 21552807
• Report Number: 0008030665-2025-00552
• Device Sequence Number: 4475364
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 03-2622-3
• Device Lot Number: 24PR01060
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2024
• 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 OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 68 KG