• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SECHRIST INDUSTRIES, INC. 3500CP-G AIR/OXYGEN MIXER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3500CP-G AIR/OXYGEN MIXER
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4225 e la palma ave
anaheim CA 92807
MDR Report Key9314668
MDR Text Key166213308
Report Number9314668
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3500CP-G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/16/2019
Event Location Hospital
Date Report to Manufacturer11/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-