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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3500CP-G
Device Problem Output Problem (3005)
Patient Problems Death (1802); Low Oxygen Saturation (2477)
Event Date 09/05/2019
Event Type  Death  
Manufacturer Narrative
This report is based solely on the reported issue of a death while in use with the sechrist mixer. Additional information was requested to determine the root cause of the failure. 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.
 
Event Description
Distributor reported on behalf of hospital that patient was operated on for a heart transplant on (b)(6) 2019. Patient is labile in terms of blood pressure, hence an increase in norepinephrine and fluids are necessary. At approximately 6:30 pm, the ecmo "goes wrong" with the map falling below 60, the doctor is called, filling on the ecmo. Then the blood pressure sharply drops to 40 of map. The doctor arrives immediately and does an ultrasound, patient filled by pvc and increase in noradrenaline; o2vs falls. The staff notice that the scanning is decreased (3 initially the registered nurse did not turn the knob and performed the ecmo monitoring at 6:15 pm) and that the ecmo cannulas were dark and with no marked visible difference. Doctors notice that the scanning adjustment knob is sensitive. During this time adrenaline and fluids are continued. The patient stabilizes around 6:50 pm with correct saturation and map. Patient died on (b)(6) 2019. The analysis of the causes is in progress.
 
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Brand NameSECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4225 e. la palma avenue
anaheim CA 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 e. la palma avenue
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4225 e. la palma avenue
anaheim, CA 92807
MDR Report Key9168739
MDR Text Key161656476
Report Number2020676-2019-00018
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? Yes
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 Manufacturer11/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/08/2019 Patient Sequence Number: 1
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