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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS MIXER 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 Type  malfunction  
Manufacturer Narrative
Evaluation of the returned device found the unit will not increase fio2 from baseline reading. The unit fio2 is out of calibration and is stuck at around 21. 3 fio2, the balance is affected due to the fio2 not increasing. Based on the age of the device, it is unlikely 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. Mixers are multi-use, serviceable items. As such, it is anticipated that the units may occasionally require repair, and as part of standard care, the mixer should be inspected prior to use. If damage or functional issues are noted during these routine mixer inspections, the unit should not be put into use with a patient and should be reported to sechrist for servicing. Manufacturer reference file # (b)(4).
 
Event Description
Customer reported cannot measure the oxygen %, but when turned to 60, it "sits at 20". The issue was discovered at set-up. No patient incident was reported.
 
Event Description
Customer reported cannot measure the oxygen %, but when turned to 60, it "sits at 20". The issue was discovered at set-up. No patient incident was reported.
 
Manufacturer Narrative
Evaluation of the returned device found the unit will not increase fio2 from baseline reading. The unit fio2 is out of calibration and is stuck at around 21. 3 fio2, the balance is affected due to the fio2 not increasing. Based on the age of the device, it is unlikely 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. Mixers are multi-use, serviceable items. As such, it is anticipated that the units may occasionally require repair, and as part of standard care, the mixer should be inspected prior to use. If damage or functional issues are noted during these routine mixer inspections, the unit should not be put into use with a patient and should be reported to sechrist for servicing. Manufacturer reference file # (b)(4).
 
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Brand NameSECHRIST AIR/OXYGEN GAS MIXER 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 Key13053487
MDR Text Key285393981
Report Number2020676-2021-00036
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 Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
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 Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2017
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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