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".

Manufacturer Narrative

Summary: the mixer was received and checked for damage before being tested and it was found that the mixer's fi02 knob was detached from the mixer, the water trap was broken off and the flow meter knob on the 100-1000 ml/ min flow meter was pushed in.The biomed technician was contacted and he stated that the unit was damaged during shipping.The technician was asked about the mixer knob and the biomed technician stated that the knob was loose when he received it.The biomed technician was asked if the unit was checked before the unit goes in to use and his answer was yes.The biomed technician was asked about preventive maintenance and he could not answer when the last time that the unit had been overhauled or maintenance was.A check of the service records found this mixer was due in for a sechrist overhaul in 2004; this mixer has not been returned to sechrist until july 2018 for this reported complaint.This mixer is 14 years past due for overhaul evaluation: the mixer knob was examined and it was noticed that one of the set screws was missing from the unit, no testing could be done as the unit was found so the mixer knob was reattached and set, the unit was tested and there were no observations of it being outside of required specifications were found during testing of the unit.Root cause: the reported issue is due to the unit not being overhauled every two years per the recommended mixer's user's manual.

Event Description

Supplemental medwatch is being submitted for more information received and product evaluation findings.

• 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
• 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
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• 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
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1