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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2026
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 charge nurse reported that transducers included with the combiset are interfering with treatments.There are reoccurring transmembrane pressure (tmp) alarms and increased pressures in venous chamber making blood backflow into lines.9 times out of 10, transducers with the combiset are change out with the spare transducer supplies.The new style cap on the end of heparin lines does not thread and secure efficiently.When pressures build up, the cap has blood off the end, potentially having blood loss.The combiset from about a year ago was probably the most efficient product.Upon follow up, the nurse reported that the 2008t with bibag machines produce tmp alarms right before the increased pressure in the venous chamber causes blood backflows through the lines and into the saline.Approximately 10-100ml of blood entered the saline and the blood was not returned.The nurse verified that there were no external leaks.The nurse stated the facility receives both old and new types of transducers but only noticed issues with the reported lot number 26br01045 since 5/25/2026.The nurse stated that the new transducer caps for the heparin line don't tighten enough and feel like there's stripped threads.The patients were able to complete treatments using the same machines and spare supplies.There were no patient injuries or medical interventions required as a result of the events.The nurse could not confirm at the time if the bloodlines and transducers were available to be returned for physical analysis.Upon further follow up, the nurse reported that there were 6 cases that involved the bloodlines lot number and they are available to be returned for physical analysis.The 9 times out of 10 report was related to the tmp alarms that were addressed with using a spare transducer.The events did not always involve a back flow of blood.Upon further follow up, the nurse confirmed that the 6 saved samples are unused bloodline companion samples from the same lot number.The 9 times out of 10 report was an approximate percentage of times tmp alarms were addressed with using a spare transducer but not an exact number of occurrences.

• 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: 25585440
• Report Number: 0008030665-2026-01331
• Device Sequence Number: 12187669
• Product Code: FJK
• UDI-Device Identifier: 00840861102402
• UDI-Public: 00840861102402
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/29/2026

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: 03-2522-1
• Device Lot Number: 26BR01045
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• 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: 09/29/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE
• Patient Sex: Unknown