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

Model Number 3500CP-G

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on the customer's reported issue.The device is serviced by a 3rd party and not available for return to the manufacturer.Review of dhr for this mixer 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.Based on the age of the device the likely cause is normal wear and tear.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 refenced file #(b)(4).

Event Description

Customer reported the patient under cec ecls is admitted to intensive care at 9:30 p.M.By the smur (emergency rapid response unit) in (b)(6).On arrival the patient requires an increase in fio2 on the sechrist.However, it is impossible on the latter to make a rotation beyond 80% with the sechrist wheel.

• Brand Name: SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 11646180
• MDR Text Key: 247158553
• Report Number: 2020676-2021-00009
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 3500CP-G
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1