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

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".

• Brand Name: 3500 CP-G AIR/OXYGEN MIXER
• Type of Device: MIXER
• 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 Key: 7675591
• MDR Text Key: 113641917
• Report Number: 2020676-2018-00009
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• 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 Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3500CP-G
• Device Catalogue Number: 3500 - MIXER S/A,AIR/O2,IV100B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/1983
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse