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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES INC. 3500CP-G AIR/OXYGEN MIXER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3500CP-G
Device Problem Increase in Pressure (1491)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
Sechrist industries has made numerous attempts to obtain further information from the user facilty and the only information received from the initial reporter is that she is no longer in the patient safety coordinator role and that she has no further information other than what was reported on their medsun report sent to the fda. Review of the device history records for the mixer found it was built in 2013 and no non-conformances were found in the manufacturing of the mixer. Review of service history records for this serial number mixer found that this mixer has not been returned to sechrist for preventative maintenance as recommended in the user's manual. Complaint review, for past twelve months, for similar devices, found no similar incidents. 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 references incident (b)(4).
 
Event Description
Sechrist received a medsun mandatory and voluntary report form uf/importer report # (b)(4) in the regular mail from the department of health & human services, food and drug administration on december 09, 2019. The user facility report states " on 2 separate occasions with 2 different ecmo circuits, the ecmo circuit's seep flow meter (oxygen blender) increased without ecmo specialist's manipulation. No adverse event reported or patient involvement provided. See manufacturer report 2020676-2020-00001 / incident (b)(4) for the first report.
 
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Brand Name3500CP-G AIR/OXYGEN MIXER
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 ave.
anaheim, CA 92807
7145798309
MDR Report Key9555929
MDR Text Key208569130
Report Number2020676-2020-00002
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DTX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number3500CP-G
Device Catalogue Number3500CP-G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2013
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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