MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number	03-2794-0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/10/2025
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 patient care technician (pct) from a hemodialysis (hd) user facility reported that a combi set blood leak occurred during a patient¿s hd treatment.The blood leak occurred when the flow line was reversed.It was reported that the sample was not available to be returned for evaluation.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.
Event or Problem Description
Additional details were provided upon follow-up with the pct who initially reported the event.The blood leak occurred approximately thirty minutes into hd treatment.The machine prompted the operator to twist the lines to reverse the flow, and blood started leaking from the twister component when the lines were twisted.The tubing did not disconnect - it remained attached.There were no visible defects at or near the leak location.There were no machine alarms that occurred.The pct confirmed there were no changes in pressure.Once the leak was noticed, the lines were twisted back to stop the leak.The leaking stopped and the patient's blood was able to be returned.The patient was disconnected and re-setup with new supplies.The patient completed their treatment on the same machine.The patient's estimated blood loss (ebl) due to the leak was <3 ml.There was no patient 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 evaluation as it was reportedly discarded.
Event or Problem Description
Additional details were provided upon follow-up with the pct who initially reported the event.The blood leak occurred approximately thirty minutes into hd treatment.The machine prompted the operator to twist the lines to reverse the flow, and blood started leaking from the twister component when the lines were twisted.The tubing did not disconnect - it remained attached.There were no visible defects at or near the leak location.There were no machine alarms that occurred.The pct confirmed there were no changes in pressure.Once the leak was noticed, the lines were twisted back to stop the leak.The leaking stopped and the patient's blood was able to be returned.The patient was disconnected and re-setup with new supplies.The patient completed their treatment on the same machine.The patient's estimated blood loss (ebl) due to the leak was <3 ml.There was no patient 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 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.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 21516833
• Report Number: 0008030665-2025-00512
• Device Sequence Number: 8378443
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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: 03-2794-0
• Device Lot Number: 24PR01090
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/05/2025; 03/19/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/05/2025; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2024
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 70 KG