MAUDE Adverse Event Report: SECHRIST INDUSTRIES INC. SECHRIST INDUSTRIES INC.; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	3500CP-G24
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Eu distributor informing sechrist of customer reporting that the mixer had blood inside and several components were heavily corroded.No patient involvement or injury reported.Neither customer nor distributor reported to fda according to the information we have at this time.Device in question will not be evaluated by sechrist as eu distributor will evaluate.Sechrist informed eu distributor if mixer is confirmed to be contaminated with blood internally, the mixer is to be decommissioned and disposed of properly.At this time, the report is based on the information we have.We have requested more information from our distributor in regard to service records and disposition of the device in question.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: (b)(4).
Event or Problem Description
Eu distributor informing sechrist of customer reporting "blood inside mixer and several components heavily corroded." no patient/user injury reported.

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma avenue; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 21529721
• Report Number: 2020676-2025-00010
• Device Sequence Number: 9584978
• Product Code: BZR
• UDI-Device Identifier: 00852682007491
• UDI-Public: 00852682007491
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K992503
• 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): 03/05/2025

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-G24
• Device Lot Number: 88768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2016
• 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