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 No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on the customer medsun report no.: (b)(4).Customer was contacted in reference to the reported incident and no additional information was provided.A dhr review of the reported serial number 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.The instructions for use state, the lifetime of sechrist air/oxygen mixers is 20 years provided they are overhauled using sechrist supplied components and sechrist certified technicians once every 2 years.Based on the age of the device, it appears the device has outlived it's useful life.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 #: (b)(4).

Event Description

Customer reported post oxygenator gas drawn to get a baseline with the new oxygenator.Post oxy po2 was 69mmhg.Switched the circuit to an oxygen tank instead of the gas blender and redrew a post oxygenator gas which resulted in a po2 of 410mmhg, indicating an issue with the blender.Exchanged the blender on the ecmo cart for a new one.Checked another post oxygenator gas with the new gas blender, and the po2 was 366mmhg.The issue was discovered while in use with a patient.Medical intervention was required.

• 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: 10909345
• MDR Text Key: 219141564
• Report Number: 2020676-2020-00024
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/03/2020
• Initial Date FDA Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/1987
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR