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	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician reported that the tubing on a combi set ¿broke¿ during a patient¿s hemodialysis (hd) treatment.Additional clarification was obtained through follow-up with a registered nurse (rn) from the facility.The rn reported that a blood leak was observed coming from the combi set less than five minutes after the start of treatment.Blood was observed leaking externally from the ¿t¿ connection on the arterial side of the lines, where the heparin line connects.The heparin line remained intact according to the rn; it did not separate or disconnect.There were no visible defects noted at the leak location.The rn stated there was no leaking noted during the priming phase.Additionally, there were no alarms from the machine.Once the leak was noticed, the patient¿s blood was returned.The patient¿s estimated blood loss (ebl) from the leak was less than 20 ml.The rn 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 confirmed to be available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint sample was returned to the manufacturer for physical evaluation.The product was not in its original packaging.As the sample was being disinfected and prepared for analysis, a leak was found between the heparin line and the red ¿t¿ connector.Additionally, the heparin line separated from the red ¿t¿ connector.Further visual inspection under a microscope found that the solvent on the heparin line was not applied properly.There was a lack of solvent at the union between the heparin line and red ¿t¿ connector.There are several different possibilities for the cause of the reported failure.No other problems or abnormalities were identified during the evaluation.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.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.The investigation into the complaint was able to confirm the reported event.
Event or Problem Description
A user facility biomedical technician reported that the tubing on a combi set ¿broke¿ during a patient¿s hemodialysis (hd) treatment.Additional clarification was obtained through follow-up with a registered nurse (rn) from the facility.The rn reported that a blood leak was observed coming from the combi set less than five minutes after the start of treatment.Blood was observed leaking externally from the ¿t¿ connection on the arterial side of the lines, where the heparin line connects.The heparin line remained intact according to the rn; it did not separate or disconnect.There were no visible defects noted at the leak location.The rn stated there was no leaking noted during the priming phase.Additionally, there were no alarms from the machine.Once the leak was noticed, the patient¿s blood was returned.The patient¿s estimated blood loss (ebl) from the leak was less than 20 ml.The rn 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 confirmed to be available to be returned for manufacturer evaluation.

• 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: 21939946
• Report Number: 0008030665-2025-00988
• Device Sequence Number: 8547726
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/28/2025

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: 25CR01071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG