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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC 3500CP-G - MIXER, GENERAL GAS CONTROL UNIT, CARDIOPULMONARY BYPASS, PRODUCT CODE: DTX

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SECHRIST INDUSTRIES, INC 3500CP-G - MIXER, GENERAL GAS CONTROL UNIT, CARDIOPULMONARY BYPASS, PRODUCT CODE: DTX Back to Search Results
Model Number 3500CP-G
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned device found the fio2 knob would not turn and the gas concentration output is at (b)(4)% o2. The balance regulator readings are all out of specification. Both the top and bottom set screws and the fio2 knob are loose. The loose components allowed the fio2 knob to slip on the shaft causing the knob to become stuck and the readings to be out of specification. Review of dhr 3500cp-g mixer sn (b)(4) (manufactured 09/05/2019) found no indication that there were any relevant discrepancies during manufacture of the device and no non-conformance that could have caused or contributed to the reported issue. 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. Mixers are multi-use, serviceable items. As such, it is anticipated that the units may occasionally require repair, and as part of standard care the mixer should be inspected prior to use. If damage or functional issues are noted during these routine mixer inspections, the unit should not be put into use with a patient and should be reported to sechrist for servicing. Manufacturer reference file #(b)(4).
 
Event Description
Customer reported while using mixer, found o2 level output on o2 analyzer would not go above 30%. Patient was being treated for less than 1-minute when issue was discovered. There was no serious injury or impact to patient reported.
 
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Brand Name3500CP-G - MIXER, GENERAL
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS, PRODUCT CODE: DTX
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim CA 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4225 e. la palma ave.
anaheim, CA 92807
7145798309
MDR Report Key10603167
MDR Text Key209856291
Report Number2020676-2020-00013
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2019
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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