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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES INC. 3500 CP-G AIR/OXYGEN MIXER Back to Search Results
Model Number 3500CP-G
Device Problem Gas Output Problem (1266)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/09/2018
Event Type  malfunction  
Manufacturer Narrative
Customer service has contacted the customer for the return of the mixer for investigation but it has not been returned to date. If and when it is received a supplemental medwatch report will be submitted. A review of the manufacturing service records indicate that the device was manufactured on 12/20/1982. The last date of overhaul by sechrist was performed on 10-18-2002. User's manual recommends in order to assure proper function and accuracy, the sechrist air/oxygen mixers must be thoroughly overhauled every two (2) years. To maintain the product warranty, this overhaul must be performed by sechrist industries or by sechrist authorized personnel. Customer service recommended to customer to return the mixer to be overhauled. (b)(4).
 
Event Description
The nurse was using the sechrist air/o2 mixer on their ecmo system. They take arterial blood gases from the oxygenator in addition to the patient while on ecmo. The oxygenator po2s generally run 450 to 500. After 4 days on ecmo, they noticed the po2 dropping on the oxygenator to the 200s. They repeated the gas and it was also low. So the first action was to change out the oxygenator because they thought it might have a clot in it or the membrane was failing. They could visualize no problems with it once it was replaced. After the oxygenator changeout, several oxygenator blood gases were drawn on the new oxygenator and they were in the low 200s just like before. They anticipated over 500 po2. Ruling out the oxygenator, they then switched the oxygen and compressed air lines coming from the sechrist blender to different wall receptacles and again took samples from the oxygenator. The po2s were still lower so they then connected their oxygen line to the oxygenator to an oxygen tank, completely bypassing the sechrist blender. The blood gas from the oxygenator using the oxygen tank showed over 500. That seemed to indicate the problem was in the sechrist blender. At that point they retrieved another sechrist blender from one of the heart lung machines and connected it to their ecmo system. The first several blood gases and subsequent blood gases were all in the 450 - 500 range as was to be expected. Because of those troubleshooting measures, they believed the problem to be the original sechrist blender. Email thread from customer states "no patient was harmed".
 
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Brand Name3500 CP-G AIR/OXYGEN MIXER
Type of DeviceMIXER
Manufacturer (Section D)
SECHRIST INDUSTRIES INC.
4225 e. la palma avenue
anaheim, ca 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4224 e. la palma avenue
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4224 e. la palma avenue
anaheim, CA 92807
7145798309
MDR Report Key7675591
MDR Text Key113641917
Report Number2020676-2018-00009
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,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3500CP-G
Device Catalogue Number3500 - MIXER S/A,AIR/O2,IV100B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/1983
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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