MAUDE Adverse Event Report: SECHRIST INDUSTRIES SECHRIST AIR/OXYGEN GAS MIXER MODEL 3500CP-G; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number	3500CP-G
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
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.Review of dhr 3500cp-g mixer sn (b)(6) found no indication that there were any relevant discrepancies during manufacture of the device and no non-conformance that could have caused or contributed to the reported issue.At this time there is 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).
Event or Problem Description
Customer reported the device has blood inside, during an accidental situation that makes the device unfeasible to use.No patient injury was reported.The device has been decommissioned.

• Brand Name: SECHRIST AIR/OXYGEN GAS MIXER MODEL 3500CP-G
• 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: majid mashayekh ; 4225 e. la palma ave.; anaheim, CA 92807
• MDR Report Key: 21160393
• Report Number: 2020676-2025-00001
• Device Sequence Number: 15346894
• Product Code: DTX
• UDI-Device Identifier: 00899660002345
• UDI-Public: 00899660002345
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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 Model Number: 3500CP-G
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2017
• 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