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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 GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

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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 06/08/2020
Event Type  malfunction  
Event Description
Customer reported the sechrist gas blender found to be delivering only 60% oxygen with the fio2 dial set at 100%. No patient incident was reported.
 
Manufacturer Narrative
Blender removed from patient circuit, tested and sent for repair. No consequence to patient was reported. Service record, provided by the customer, indicates the unit was serviced after the incident. There was no physical damage noted. The unit was disassembled, cleaned and disinfected. Replaced diaphragms, all o-rings and filters. Calibrated and verified oxygen mix and alarm set points. Performed flow and pressure tests per oem standard and verified o2 readings. Unit was returned in working condition. Therefore, the likely root cause can be attributed to normal wear and tear. A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue. Based on the age of the device (mfg date feb. 2011), it is unlikely that a manufacturing non-conformance contributed to the reported issue. Therefore, no corrective or preventative actions are necessary. User facility did not provide additional information regarding the incident. The issue was discovered prior to use and there was no patient involvement. The user's manual states, 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. " 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.
 
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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 Key14466435
MDR Text Key300360651
Report Number2020676-2022-00009
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 05/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2022
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
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2011
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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