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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN, 20112-OBSOLETE-MIXER-TERUMO OXYGENATOR, CARDIOPULMONARY BYPASS

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SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN, 20112-OBSOLETE-MIXER-TERUMO OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 20112
Device Problems No Audible Alarm (1019); Inaccurate Flow Rate (1249)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2019
Event Type  malfunction  
Manufacturer Narrative
Customer was provided with a return material authorization number to return the mixer for inspection, numerous attempts to the customer have been made for more information or to retrieve the device, but none has been forthcoming. If more information or the device is returned a follow up supplemental report will be sent. Review of the device history for the mixer 20112 (obsolete) found it was manufactured on 08/31/1989. Review of the device history found that the mixer has exceeded the life expectancy of sechrist mixer's which is 20 years provided they are overhauled using sechrist supplied components, as well as sechrist certified technicians, every two years. 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
Customer reported that during clinical use, there was a reduction in flow to the patient and the alarm did not go off. They were able to get the patient switched to another mixer right away, so no patient injury.
 
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Brand NameSECHRIST AIR/OXYGEN, 20112-OBSOLETE-MIXER-TERUMO
Type of DeviceOXYGENATOR, 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 avenue
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4225 e. la palma avenue
anaheim, CA 92807
MDR Report Key9316488
MDR Text Key197769858
Report Number2020676-2019-00021
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 distributor,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20112
Device Catalogue Number3500CP-G
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/1989
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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