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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500B- OBSOLETE-MIXER, BAXTER OXYGENATOR, CARDIOPULMONARY BYPASS

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SECHRIST INDUSTRIES, INC. 3500B- OBSOLETE-MIXER, BAXTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3500B
Device Problem Inaccurate Delivery (2339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturer evaluation results: the mixer was received and was found to be out of specification when tested the unit ranges from plus 1. 5 above the set value to minus 2. 7 below the set value at. 30 and 1. 00 fi02 respectively. The reason for the failure is device is out of calibration. The device history record review found the mixer was manufactured in 1985 and no indication in the manufacturing of any non-conformances that could cause or contribute to the reported issue. User's manual states: the sechrist air/oxygen mixer is a "precision pressure regulation and proportioning device, which is designed to accurately mix medical grade air and medical grade oxygen (02). Prior to each clinical usage, the user should perform an alarm test and analyze the full fio2 range. With an accurately calibrated oxygen analyzer, the user should analyze the fio2 at the following settings; 21%, 40%, 60%, 80%, and 100%. Additionally, the user should briefly disconnect one supply gas to assure that the bypass/alarm system is functioning. With a single supply gas disconnected, the audible alarm should sound and the analyzed fio2 should indicate the fio2 of the single supply gas; i. E. 21% if the oxygen was disconnected and 100% if the air supply was disconnected.
 
Event Description
During clinical use, customer found that o2 was not delivering appropriate amount ("was way under delivering), o2 was being monitored by staff and they immediately switched mixers. Mixer was removed from service. Patient was not injured. Clinical engineering tested unit at 100% and unit was only delivering 80%. Tested at 60% and was delivering 40%. Patient was not injured.
 
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Brand Name3500B- OBSOLETE-MIXER, BAXTER
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4224 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
7145798309
MDR Report Key8895435
MDR Text Key216230639
Report Number2020676-2019-00012
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 07/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3500B
Device Catalogue Number3500B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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