MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500 CP-G AIR OXYGEN MIXER; OXYGENATOR, CARDIOPULMONARY BYPASS

Device Problem Device Operational Issue (2914)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

The 3500cp-g mixer, serial number (b)(4), was returned due to the reported issue of the mixer unit failing "to oxygenate and flow co2"during patient use.No patient injury.The device did not oxygenate and flow gas due to improper usage by the user.The 3500cp-g 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.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 not being overhauled per the manufacturer's recommended interval of every 2 years.A dhr (device history review) was performed.The 3500cp-g mixer, serial number (b)(4), was manufactured on 6/11/2015.There is no indication that there were any relevant discrepancies during manufacturing.Device history record (dhr) did not find any non-conformance that could cause or contribute to the reported issue.

Event Description

It was reported that mixer did not oxygenate and flow co2 during use.No patient injury was reported.

• Brand Name: 3500 CP-G AIR OXYGEN MIXER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma avenue; anaheim, CA 92807
• MDR Report Key: 7329454
• MDR Text Key: 102202922
• Report Number: 2020676-2018-00004
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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