MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-2622-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/24/2024
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 the rn.The blood leak occurred at the very beginning of treatment.The machine, a fresenius 2008t machine, alarmed with an air detector alarm.The staff noticed blood leaking from the tubing in the blood pump.There were no leaks during the priming phase.The patient¿s blood was unable to be returned; estimated blood loss (ebl) was 400 ml.The machine was re-setup with new supplies so the patient could continue their treatment.When the bloodline tubing was removed from the machine, a nick was found on the tubing in the same area where the leak was coming from.After restarting with new supplies, the patient was able to complete their treatment without further incident.The rn confirmed 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
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 shipping history search was performed to identify all lot numbers from the reported catalog number that were delivered to the user facility for a three (3) month time frame immediately preceding the event occurrence date.There were no results found using this search criteria.As such, a manufacturing review could not be performed and an investigation of the device history records (dhr) was unable to be conducted.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 the rn.The blood leak occurred at the very beginning of treatment.The machine, a fresenius 2008t machine, alarmed with an air detector alarm.The staff noticed blood leaking from the tubing in the blood pump.There were no leaks during the priming phase.The patient¿s blood was unable to be returned; estimated blood loss (ebl) was 400 ml.The machine was re-setup with new supplies so the patient could continue their treatment.When the bloodline tubing was removed from the machine, a nick was found on the tubing in the same area where the leak was coming from.After restarting with new supplies, the patient was able to complete their treatment without further incident.The rn confirmed 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.

• Brand Name: 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: 20870744
• Report Number: 0008030665-2024-01205
• Device Sequence Number: 18283902
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: 03-2622-3
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/30/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 67 KG