MAUDE Adverse Event Report: SECHRIST INDUSTRIES. INC. SECHRIST LOW FLOW OXYGENATOR

Model Number 20400

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on the customer's medwatch report.Correction to user's facility medsun medwatch model # from 3500 to 20400.Review of the device history records show ' mixer model 20400 s.N.(b)(4) was manufactured on 1/06/2005.A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.A search of the service records show that the unit has not been back to sechrist every two years for mandatory overhaul/service.

Event Description

Information received from a user facility medwatch report # (b)(4) was received on (b)(6) 2019 from fda - "cardiopulmonary bypass circuit wasn't oxygenating and the problem was eventually traced back to the blender not functioning properly.It was set to 100% oxygen with a flow over ten as was unable to deliver oxygen.An oxygen tank was brought in and was able to oxygenate when connected directly to the oxygenator.Sales rep from a company that we are contracted with to support this product were on site to test the device.They agreed device was not supplying oxygen(their sensor readings were 21%).The rep noted that one of the two screws for the dial on the control knob was loose.He tightened the screw and the device worked - delivering close to 100% 02".

• Brand Name: SECHRIST LOW FLOW OXYGENATOR
• Type of Device: LOW FLOW OXYGENATOR
• Manufacturer (Section D): SECHRIST INDUSTRIES. INC.; 4225 e. la palma avenue; anaheim, ca 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4224 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4224 e. la palma avenue; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 8609201
• MDR Text Key: 146374215
• Report Number: 2020676-2019-00010
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20400
• Device Catalogue Number: 20400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2005
• 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