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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G LOW FLOW GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

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SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G LOW FLOW 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 11/28/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned device found the proportional valve and the balance regulator, on the gas blender, were out of calibration. The fio2 knob was loose and a set screw was missing. This did not allow the balance regulator to adjust the fio2 properly. Additional information received by the customer indicate that this device is only checked for functionality and has not been overhauled or preventative maintenance performed on it. A dhr review of this device found no indication that there were any relevant discrepancies during manufacture of the device, and no non-conformance that could have caused or contributed to the reported issue. Based on the age of the device, it is likely that normal wear and tear contributed to the malfunction. 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
Customer reported patient was on ecmo machine and o2 was set to 100%, but found that blood was wrong color, so they switched blenders. No injury to the patient as they noticed immediately, and took immediate action.
 
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Brand NameSECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G LOW FLOW
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 Key11049494
MDR Text Key223192438
Report Number2020676-2020-00027
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 12/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
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 Manufacturer12/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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