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	06/14/2025
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 approximately eighty-four minutes into a patient¿s hemodialysis (hd) treatment.There were two small drops of blood noted on the base of the machine.The blood leak was coming from the portion of the tubing that is placed inside the blood pump.There was a small pinhole observed at the center of the tubing.Blood from the arterial line was returned.Blood from the venous line could not be returned.The patient's estimated blood loss was 200ml.There were no machine alarms.No damage or defects were noted on the lines prior to use, and no loose connections were noticed.The nm confirmed there were no leaks during the priming phase.There were no changes or disruptions in pressure that could have contributed to the leak.The patient did not experience any adverse effects or require medical intervention due to the blood loss.The patient was re-setup with new supplies and completed their treatment on the same machine.The blood pump was inspected following the event and no sharp edges were noted.The combi set was not available to be returned for evaluation.
Event or Problem Description
A user facility nurse manager (nm) reported that a combi set blood leak occurred approximately eighty-four minutes into a patient¿s hemodialysis (hd) treatment.There were two small drops of blood noted on the base of the machine.The blood leak was coming from the portion of the tubing that is placed inside the blood pump.There was a small pinhole observed at the center of the tubing.Blood from the arterial line was returned.Blood from the venous line could not be returned.The patient's estimated blood loss was 200ml.There were no machine alarms.No damage or defects were noted on the lines prior to use, and no loose connections were noticed.The nm confirmed there were no leaks during the priming phase.There were no changes or disruptions in pressure that could have contributed to the leak.The patient did not experience any adverse effects or require medical intervention due to the blood loss.The patient was re-setup with new supplies and completed their treatment on the same machine.The blood pump was inspected following the event and no sharp edges were noted.The combi set was not available to be returned for evaluation.
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.

• 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: 23251435
• Report Number: 0008030665-2025-02409
• Device Sequence Number: 13323493
• 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
• Report Date (Section B): 11/26/2025

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
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 63 KG