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	12/05/2024
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 clinical manager (cm) reported that a combi set bloodline separated during a patient¿s hemodialysis (hd) treatment.The separation occurred three hours into the patient¿s three-and-a-half-hour treatment.The saline line reportedly ¿popped off¿ at the t-connection to the arterial bloodline.The cm stated it was almost as if the line was not properly adhered to the connector.A staff member was at the machine when this occurred, and they were able to immediately clamp off the lines.The patient¿s treatment was discontinued.There were no machine alarms that occurred, and there were no other known issues leading up to the event.The cm stated that everything else seemed normal.The patient¿s blood was not returned.Between blood that leaked due to the separation and blood contained within the circuit, the patient¿s estimated blood loss (ebl) was 325 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.It was confirmed that the sample was available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.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 clinical manager (cm) reported that a combi set bloodline separated during a patient¿s hemodialysis (hd) treatment.The separation occurred three hours into the patient¿s three-and-a-half-hour treatment.The saline line reportedly ¿popped off¿ at the t-connection to the arterial bloodline.The cm stated it was almost as if the line was not properly adhered to the connector.A staff member was at the machine when this occurred, and they were able to immediately clamp off the lines.The patient¿s treatment was discontinued.There were no machine alarms that occurred, and there were no other known issues leading up to the event.The cm stated that everything else seemed normal.The patient¿s blood was not returned.Between blood that leaked due to the separation and blood contained within the circuit, the patient¿s estimated blood loss (ebl) was 325 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.It was confirmed that the sample was available to be returned for manufacturer evaluation.

• 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: 21013975
• Report Number: 0008030665-2024-01352
• Device Sequence Number: 8342820
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 24HR01149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/24/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2024
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 58 KG