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

Model Number 3500CP-G

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned device did not confirm the reported issues.The gas blender is working as expected.No malfunctions, or failures were found.A dhr review of this device 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 #: (b)(4).

Event Description

Customer reported patient was on ecmo machine and o2 was set to 100%, but found that blood was wrong color, so they switched blenders.No injury to the patient as they noticed immediately, and took immediate action.

• Brand Name: SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G LOW FLOW
• 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: 11049734
• MDR Text Key: 223174939
• Report Number: 2020676-2020-00028
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2020
• 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