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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Nausea (1970); Vomiting (2144)
Date of Event	06/13/2025
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
The director of nursing (dn) from a hemodialysis (hd) user facility reported that a blood leak occurred during a patient¿s hd treatment.The blood leak was noted to be coming from the blood pump.According to the nurse operating the machine, it seemed like the bloodline tubing may have ¿erupted¿.Additional details were obtained through follow-up with the dn, as well as the head biomedical technician (biomed).An alarm for low blood pressure was what initially drew the staff¿s attention.At approximately thirty-two minutes into the treatment, the operating nurse noticed blood dripping from the blood pump.There was no blood pump alarm.The blood leak resulted in an estimated blood loss (ebl) of 200 ml.Per standing orders, the patient was given a saline bolus (volume unspecified) to address the low blood pressure (bp).The patient¿s bp initially went up following administration of the bolus.The patient was re-setup with new supplies on a different machine where they were able to complete treatment.They continued to monitor the patient¿s bp throughout the treatment.Approximately an hour after restarting the treatment, the patient complained of nausea and began vomiting.Despite this, the treatment was not ended, and the symptoms eventually faded.The patient¿s bp was stable upon completion of treatment and the dn said the patient was not in any acute distress.The patient did not receive any medical intervention to address the nausea and vomiting.The patient was sent home and continues to perform incenter hd therapy without further issue.The dn said the machine that was in use when the leak occurred was removed from service for evaluation.The bloodlines remained attached when it was removed from the floor and due to time constraints, the staff did not have an opportunity to inspect the lines.According to the biomed, the bloodlines were not connected to the machine when they performed their evaluation.The bloodlines were reportedly in a bag, and the biomed did not inspect them before they were discarded.The front of the machine was reportedly covered in blood stains and the blood pump rotor was also very bloody.The biomed said there was nothing wrong with the blood pump rotor itself.The caps were intact on all of the blood pump rotor pins, and there did not appear to be any defects or damage on the part.The biomed replaced the blood pump rotor, even though there was nothing wrong with it.The biomed stated they did this because it was covered in blood.The biomed confirmed they performed testing on the machine, and that it passed testing.The biomed was not clear if the testing was performed on the machine before or after the blood pump rotor was replaced.The biomed did not have any photos of the replaced rotor.The machine was subsequently returned to service.No sample was available for manufacturer evaluation.
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.
Event or Problem Description
The director of nursing (dn) from a hemodialysis (hd) user facility reported that a blood leak occurred during a patient¿s hd treatment.The blood leak was noted to be coming from the blood pump.According to the nurse operating the machine, it seemed like the bloodline tubing may have ¿erupted¿.Additional details were obtained through follow-up with the dn, as well as the head biomedical technician (biomed).An alarm for low blood pressure was what initially drew the staff¿s attention.At approximately thirty-two minutes into the treatment, the operating nurse noticed blood dripping from the blood pump.There was no blood pump alarm.The blood leak resulted in an estimated blood loss (ebl) of 200 ml.Per standing orders, the patient was given a saline bolus (volume unspecified) to address the low blood pressure (bp).The patient¿s bp initially went up following administration of the bolus.The patient was re-setup with new supplies on a different machine where they were able to complete treatment.They continued to monitor the patient¿s bp throughout the treatment.Approximately an hour after restarting the treatment, the patient complained of nausea and began vomiting.Despite this, the treatment was not ended, and the symptoms eventually faded.The patient¿s bp was stable upon completion of treatment and the dn said the patient was not in any acute distress.The patient did not receive any medical intervention to address the nausea and vomiting.The patient was sent home and continues to perform incenter hd therapy without further issue.The dn said the machine that was in use when the leak occurred was removed from service for evaluation.The bloodlines remained attached when it was removed from the floor and due to time constraints, the staff did not have an opportunity to inspect the lines.According to the biomed, the bloodlines were not connected to the machine when they performed their evaluation.The bloodlines were reportedly in a bag, and the biomed did not inspect them before they were discarded.The front of the machine was reportedly covered in blood stains and the blood pump rotor was also very bloody.The biomed said there was nothing wrong with the blood pump rotor itself.The caps were intact on all of the blood pump rotor pins, and there did not appear to be any defects or damage on the part.The biomed replaced the blood pump rotor, even though there was nothing wrong with it.The biomed stated they did this because it was covered in blood.The biomed confirmed they performed testing on the machine, and that it passed testing.The biomed was not clear if the testing was performed on the machine before or after the blood pump rotor was replaced.The biomed did not have any photos of the replaced rotor.The machine was subsequently returned to service.No sample was available 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: 22439250
• Report Number: 0008030665-2025-01545
• Device Sequence Number: 19991447
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2025

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: 25DR01213
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2025
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 64 KG