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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-G3 OXYGENATOR, CARDIOPULMONARY BYPASS

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SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G3 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3500CP-G
Device Problem Inaccurate Delivery (2339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2019
Event Type  malfunction  
Manufacturer Narrative
User facility did not return the mixer to sechrist industries for inspection and testing. The user facility sent the mixer to their own off-site service provider to investigate and service the mixer. The results were that the alarm looked like the cap was out of place which caused the reed to be out of place or pushed back causing the mixer to not alarm when it should. The problem was corrected and mixer was calibrated, tested and is working and is back in service at the user facility. Note from reporter is " blender is mounted on a standard two wheel tank cart made for two e-tanks and is used to transport the patients from or to their room". Sechrist states that "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. " user's manual for this mixer has warning statements - " risk is mitigated to the lowest reasonable level through labeling and/or instructions in the manual. Sechrist recommends completing performance verification prior to each clinical use. The verification should be conducted by qualified technical personnel. Constant attendance by qualified personnel is required whenever the device is in use. If the device should fail to perform per specification, it should be removed from use and evaluated by an authorized sechrist service technician. An oxygen analyzer and alarm are to be in-line downstream from the mixer as a secondary unit to alert the user to any issues. " sechrist references incident (b)(4).
 
Event Description
During use with a patient, the device did not alarm when o2 or air gases were low. Also, seems to be leaking gas, as tanks are running out quickly. Blender is mounted on a standard two wheel tank cart made for two e tanks and is used to transport the patients from or to their room. No patient injury reported.
 
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Brand NameSECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G3
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. la palma ave.
anaheim, CA 92807
7145798309
MDR Report Key9225673
MDR Text Key207982810
Report Number2020676-2019-00019
Device Sequence Number1
Product Code DTZ
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 faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2019
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2018
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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