MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET BLOODLINE; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Catalog Number	03-2522-1
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	Chest Pain (1776); Hemorrhage/Blood Loss/Bleeding (1888); Malaise (2359); Loss of consciousness (2418)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical review: there is a temporal and possible causal relationship between hemodialysis utilizing the 03-2522-1 combiset bloodline and the patient event of tightness in the chest followed by unresponsiveness with no blood pressure and subsequent recovery of the patient.The patient symptoms and following unresponsiveness occurred within the timeframe of the air detector alerting.The lines and chamber were found to be clotted at the time of the event.Although an air embolism was suspected, it was not confirmed as the patient recovered at the clinic and refused transport to the hospital.It is unknown if air entered the patient, however; there are mitigation's in place to stop any air from entering the patient.¿the venous drip chamber contains an ultrasonic device to monitor the drip chamber for the presence of air.If the level of blood in the chamber is too low and air is detected, the machine alarms, the blood pump stops, and the clamp occludes the venous blood tubing¿.There are other possible causes of the patient¿s chest tightness with unresponsiveness including intradialytic hypotension (idh).¿it impairs the patient¿s well-being, can induce cardiac arrhythmias, predisposes to coronary and/or cerebral ischemic events.¿ without further evaluation at the hospital, the source of the patient¿s event cannot be confirmed.The nurse examined the lines, and they appeared to be tight, and no visible leak could be seen.However, air was noted in the head of the dialyzer and from the transducer to the dialyzer.Based on the available information which included the patient adverse event, the clotting in the transducer lines and venous chamber and the report of the same issue occurring multiple times with the lines, the 03-2522-1 combiset bloodline cannot be excluded as causing or contributing to the serious adverse event experienced by the patient.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A nurse reported that during a hemodialysis (hd) treatment a patient developed chest pain during treatment due to air in the line.911 was called due to air in the lines and the venous chamber clotting which resulted in not being able to return blood to the patient.The patient developed signs and symptoms of air embolism.Additional information was obtained through follow-up with the clinical nurse.This patient was a few minutes into the hemodialysis (hd) treatment on (b)(6) 2026 utilizing the 03-2522-1 combiset bloodline when the air detectors alarmed.The patient then told the pct that the patient was not feeling well.The pct tried to return the patient¿s blood, but the chamber had already clotted on one side.Approximately 150ml of blood could not be returned.The patient then went unconscious.The patient had no blood pressure (bp) reading at this time.911 was called.The clinical nurse came to the floor.It was then that she noted the lines and chamber were clotted.At the same time, the patient was placed into trendelenburg position on his left side for suspicion of air embolism.The nurse started a new intravenous (iv) line to administer saline.600ml of normal saline (ns) was administered.The patient¿s bp was >100 (exact reading not provided).They were about to connect the patient to the aed when he took a gasping breath and became responsive.The bp was now >150.Emergency medical services (ems) arrived.The patient was alert.The patient told ems that he had tightness in his chest and then did not know what happened after that.Ems did an ekg on the patient and evaluated the patient.They wanted to transport the patient to the hospital for further assessment.The patient refused and wanted to complete the dialysis treatment.Ems agreed the hospital would likely also complete the patient¿s dialysis treatment.The physician was consulted.The patient¿s blood pressure and other vitals were stable.The physician agreed the patient could stay and complete dialysis.No air embolism was confirmed.Treatment was completed.

• Brand Name: COMBISET BLOODLINE
• 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 ; +1(617)417-5172
• MDR Report Key: 25579689
• Report Number: 0008030665-2026-01325
• Device Sequence Number: 21151536
• Product Code: FJK
• UDI-Device Identifier: 00840861102402
• UDI-Public: 00840861102402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213992
• 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): 09/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03-2522-1
• Device Lot Number: 26AR01046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 09/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 173 LB