MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500CP-G AIR/OXYGEN MIXER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 3500CP-G

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2019

Event Type  malfunction  

Event Description

It is believed that the oxygen line on the back of the extracorporeal membrane oxygenation (ecmo) blender was loose fitting.This fitting accepts 3/16 tubing and 1/4 tubing.3/16 is more secure but 1/4 was used.It is thought that this caused a decrease in oxygenation.However, this has been sent to the manufacturer for further investigation.

• Brand Name: 3500CP-G AIR/OXYGEN MIXER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e la palma ave; anaheim CA 92807
• MDR Report Key: 9314668
• MDR Text Key: 166213308
• Report Number: 9314668
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3500CP-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 DA
• Patient Weight: 3