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	03/26/2025
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
It was reported to fresenius that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional details were obtained through follow-up with the user facility¿s technical manager.The blood leak was reportedly caused by a separation on the arterial side of the bloodline.The line that separated was reportedly lacking adhesive at the connection.The technical manager stated the blood leak was noted forty-five minutes into the patient¿s treatment.The patient care technician (pct) was checking the patient's blood pressure when the leak was noticed.There were no machine alarms.There were no leaks during the priming phase.Following the leak, the patient's blood was reportedly returned.The patient's estimated blood loss (ebl) due to the event was 100 to 200 ml.The machine was re-setup with new supplies and the patient then completed their treatment.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 sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.However, a photo of the complaint device depicting the separated line was provided for review.
Event or Problem Description
It was reported to fresenius that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional details were obtained through follow-up with the user facility¿s technical manager.The blood leak was reportedly caused by a separation on the arterial side of the bloodline.The line that separated was reportedly lacking adhesive at the connection.The technical manager stated the blood leak was noted forty-five minutes into the patient¿s treatment.The patient care technician (pct) was checking the patient's blood pressure when the leak was noticed.There were no machine alarms.There were no leaks during the priming phase.Following the leak, the patient's blood was reportedly returned.The patient's estimated blood loss (ebl) due to the event was 100 to 200 ml.The machine was re-setup with new supplies and the patient then completed their treatment.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 sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.However, a photo of the complaint device depicting the separated line was provided for review.
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.However, a photo was received from the customer depicting a separation from the red ¿t¿ connector to the main arterial line.The reported event was able to be confirmed in accordance with the provided photo.

• 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: 21876938
• Report Number: 0008030665-2025-00908
• Device Sequence Number: 20746619
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/08/2025

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: 03-2722-9
• Device Lot Number: 25AR01173
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2025
• 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 OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 101 KG