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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
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 facility administrator reported a transducer was pulling air into the system.The transducer popped off while starting patient.In a follow up, the reporter said treatment was completed.There was no harm to the patient.There was no blood loss for the patient.The blood pump was stopped and new transducer was added to the lines.There is no sample/companion available to send.
Event or Problem Description
A facility administrator reported a transducer was pulling air into the system.The transducer popped off while starting patient.In a follow up, the reporter said treatment was completed.There was no harm to the patient.There was no blood loss for the patient.The blood pump was stopped and new transducer was added to the lines.There is no sample/companion available to send.
Additional Manufacturer Narrative
Plant investigation: the complaint sample is not available for manufacturer physical evaluation.A search in the system was performed to verify the product availability for companion samples at the distribution centers (dc)s.No product is currently available at the distribution centers for analysis according to the sap search.Since the complaint sample is not available neither photos or videos were provided for evaluation and during the dhr (device history record) review the lot involved does not show any non-conformances, deviations or associated rework related to the alleged complaint description, could not be confirmed.No sample has been provided at this time.The report is not confirmed.

• 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: 25640983
• Report Number: 0008030665-2026-01469
• Device Sequence Number: 9837051
• Product Code: FJK
• UDI-Device Identifier: 00840861102402
• UDI-Public: 00840861102402
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 26BR01057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown