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	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility registered nurse (rn) reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with a charge nurse (cn) from the facility.The cn stated the blood leak occurred approximately two hours into the treatment.The machine, a fresenius 2008t machine, was alarming with an air detector message.When they inspected the setup, they noticed there was air in the venous chamber, and blood was leaking from the combi set.Upon further inspection, they noticed there was a small hole in the blood pump tubing.The blood leak was coming from the small hole, and it was determined that the air had entered the circuit at the hole.After the leak was identified, the treatment was stopped.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The cn 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 completed their treatment after being re-setup with new supplies on the same machine.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.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the facility for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combi sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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 registered nurse (rn) reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with a charge nurse (cn) from the facility.The cn stated the blood leak occurred approximately two hours into the treatment.The machine, a fresenius 2008t machine, was alarming with an air detector message.When they inspected the setup, they noticed there was air in the venous chamber, and blood was leaking from the combi set.Upon further inspection, they noticed there was a small hole in the blood pump tubing.The blood leak was coming from the small hole, and it was determined that the air had entered the circuit at the hole.After the leak was identified, the treatment was stopped.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The cn 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 completed their treatment after being re-setup with new supplies on the same machine.The sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.

• 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: 23688793
• Report Number: 0008030665-2025-02892
• Device Sequence Number: 9521061
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Nurse
• Type of Report: Initial,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
• 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: 11/15/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 108 KG