MAUDE Adverse Event Report: SECHRIST INDUSTRIES SECHRIST AIR/OXYGEN GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number	3500CP-G24
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the sechrist blender does not deliver the desired amount of oxygen.No patient incident was reported.
Additional Manufacturer Narrative
This report is based solely on the customer reported issue.Additional device and event information was requested and has not been received.This device is serviced by a 3rd party and will not be returned to sechrist for evaluation.A dhr review found no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file no.: (b)(4).
Additional Manufacturer Narrative
This is follow up no.1 to report 2020676-2026-00004 based on additional information received from third party service provider.The root cause of the issue was the fio2 knob being secured properly to shaft.When the knob was turned to set position by user, it was not turning the shaft with it so the desired oxygen concentration was not being output.The user assumed the device was not functioning properly.The knob issue was corrected.The device was then tested and found to be functioning according to its specifications per the received service report.Manufacturer reference file no.: (b)(4).

• Brand Name: SECHRIST AIR/OXYGEN GAS BLENDER
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: victor arellano ; 4225 e. la palma ave.; anaheim, CA 92807
• MDR Report Key: 24749996
• Report Number: 2020676-2026-00004
• Device Sequence Number: 9229643
• Product Code: DTX
• UDI-Device Identifier: 00852682007491
• UDI-Public: 00852682007491
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K023745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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 Model Number: 3500CP-G24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown