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	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional details were obtained through follow-up with the facility¿s clinical manager (cm).The cm stated the blood leak was noticed approximately three hours into the treatment.Blood was observed dripping from the ¿t¿ connector, where the skinny heparin line connects to the hard plastic piece.There were no alarms from the machine.There were no visible defects at the leak location, and the heparin line appeared to be properly seated in the connector component.The cm stated there were no known loose connections.After the staff noticed the leak, the patient¿s blood was returned and the treatment was ended early.The patient¿s blood loss was reportedly minimal; estimated blood loss (ebl) was less than 25 ml.The cm 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 did not complete their treatment, but they did not develop any symptoms or issues because of this.The sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.
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 biomedical technician reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional details were obtained through follow-up with the facility¿s clinical manager (cm).The cm stated the blood leak was noticed approximately three hours into the treatment.Blood was observed dripping from the ¿t¿ connector, where the skinny heparin line connects to the hard plastic piece.There were no alarms from the machine.There were no visible defects at the leak location, and the heparin line appeared to be properly seated in the connector component.The cm stated there were no known loose connections.After the staff noticed the leak, the patient¿s blood was returned and the treatment was ended early.The patient¿s blood loss was reportedly minimal; estimated blood loss (ebl) was less than 25 ml.The cm 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 did not complete their treatment, but they did not develop any symptoms or issues because of this.The sample was not available to be returned for manufacturer 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.

• 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: 21869544
• Report Number: 0008030665-2025-00898
• Device Sequence Number: 20812541
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 24KR01237
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2024
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 118 KG