• 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, PRODUCT CODE: DTX

  • 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, PRODUCT CODE: DTX Back to Search Results
Model Number 3500CP-G
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2020
Event Type  malfunction  
Manufacturer Narrative
Unit was received for a routine overhaul and service technician discovered a note stating the unit "will not maintain consistent flow when on ecmo case. Ball bounces". Evaluation of the returned device was unable to confirm the reported issue but found the unit to be out of specification. Service records for the returned device shows it was last overhauled by (b)(6) in (b)(6) 2015. 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
Unit was received for a routine overhaul with a note stating "will not maintain consistent flow when on ecmo case. Ball bounces". No patient or caregiver incident was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3500CP-G AIR/OXYGEN MIXER
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS, PRODUCT CODE: DTX
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4225 e. la palma avenue
anaheim, ca
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim, ca
Manufacturer Contact
majid mashayekh
4225 e. la palma ave.
anaheim, ca 
5798309
MDR Report Key10285780
MDR Text Key202564087
Report Number2020676-2020-00007
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3500CP-G
Device Catalogue Number3500CP_G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-