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

Model Number 3500CP-C

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation results: visual inspection results : the 3500 cp-c mixer was visually inspected and the fio2 knob was found to be turned too far along the proportional shaft so as to not interact with the stop pin.Mechanical testing results: the mixer was tested as received and it was found that the fio2 readings were out of specification due to the fio2 knob was one full rotation counterclockwise of it's intended position when the unit was received from the customer.Conclusion: the failures observed during full testing per doc.(b)(4) recorded in the product evaluation section of this report are due to the failure of the device being maintained and handled properly by the user.User's manual states: the 3500cp-c mixer is a "precision gas mixing device intended for use with medical breathing air and medical breathing oxygen only" per the user's manual.Also stated in the user's manual is the "user of the sechirst air/oxygen mixer shall have sole responsibility for any malfunction, which results from improper usage.A review of the device history records and the service history records was performed and found that the mixer model 3500cp-c, s.N.(b)(4) was manufactured on 06/14/1994.There is no indication that there were any relevant discrepancies during manufacturing.A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.A review of the mixer's service history found that it was last overhauled by sechrist on 5/31/2017 and tested within specification upon release to customer.(b)(4).

Event Description

Date of occurrence: 1st case - (b)(6) 2018, age: (b)(6), gender: male.Patient went on bypass for treatment of c.A.B.G.Coronary artery bypass graft, within 3 minutes, the nurse noticed the patient's arterial blood was not fully oxygenated.It was noticed that there was a lack of oxygenation within a couple minutes of going on bypass.The surgeon/ anesthesiologist/perfusionist made the decision to take patient back off the bypass.No injury to patient.This was the first case that this happened on, and customer wasn't able to troubleshoot the reason, so they decided to change out their entire pump and circuit which led to a delay in treatment (about 10 minutes) to get everything ready again.But again, no injury.Patient was fine during the procedure as well as doing fine now.After the event, the biomed evaluated the mixer and observed the "knob can turn past the 21% stop".The customer reported that a performance verification was completed prior to the mixer being placed into service with the patient.The customer reported the last preventative maintenance they performed to the mixer was done on (b)(6) 2018.See mfr # 2020676-2018-00011 for the second report for this device.

• Brand Name: SECHRIST AIR/OXYGEN MIXER 3500 CP-C
• Type of Device: AIR/OXYGEN MIXER 3500 CP-C
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4224 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: 7701201
• MDR Text Key: 114698026
• Report Number: 2020676-2018-00010
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500CP-C
• Device Catalogue Number: 3500CP-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/1994
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR