• 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 SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G GAS CONTROL UNIT, 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 SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3500CP-G
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2022
Event Type  malfunction  
Manufacturer Narrative
The sechrist equipment was functionally checked, by service technician, without any deviation from specifications identified. No out of range values for fio2 delivery were measured and no alarm monitoring system issue was reproduced. Unit was found to be working properly. Based on service record results, provided by the customer, the unit was serviced and released for patient use. Therefore, no corrective or preventive actions are necessary. As indicated in the user's manual, as part of performance verification, the user shall "prior to each clinical usage, the user should perform an alarm test and analyze the full fio2 range. With an accurately calibrated oxygen analyzer, the user should analyze the fio2 at the following settings; 21%, 40%, 60%, 80%, and 100%. Additionally, the user should briefly disconnect one supply gas to assure that the bypass/alarm system is functioning. With a single supply gas disconnected, the audible alarm should sound and the analyzed fio2 should indicate the fio2 of the single supply gas; i. E. 21% if the oxygen was disconnected and 100% if the air supply was disconnected. " furthermore, the sechrist blender must be overhauled every 2 years. A dhr review found 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 no. (b)(4).
 
Event Description
Customer reported poor oxygenation of the equipment pn 96-490-042, sn (b)(4). The issue was discovered during clinical use as no marked color difference between arterial and venous blood was noticed at the beginning of surgery. No patient injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim CA 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4225 e. la palma ave.
anaheim, CA 92807
7145798309
MDR Report Key15196143
MDR Text Key304604703
Report Number2020676-2022-00022
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-