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

Model Number 3500 LOW FLOW

Device Problem Defective Device (2588)

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

Event Date 09/06/2020

Event Type  Injury  

Event Description

Post oxygenator gas drawn to get a baseline with the new oxygenator.Post oxy po2 was 69 mmhg.Switched the circuit to an oxygen tank instead of the blender and redrew a post oxygenator gas which resulted in a po2 of 410 mmhg, 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 blender and the po2 was 366 mmhg.Perfusionist paged biomed about the issue with the blender and will have them pick it up for inspection.

• Brand Name: OXYGEN GAS BLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e la palma ave; anaheim CA 92807
• MDR Report Key: 10739845
• MDR Text Key: 213194193
• Report Number: 10739845
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3500 LOW FLOW
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17885 DA