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

Model Number 3500 CP-G

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the mixer and flowmeters found that both of the flowmeters were broken at the top.The mixer could not be tested with the customer's returned flowmeters.The customer was contacted and inquired if the unit was damaged before the unit was shipped, the customer reported there was no damage before shipping.The broken flowmeters were due to customer not providing adequate packaging to ensure the mixer would not be damaged during shipping.The overhaul label is missing on the mixer.Qe tested the mixer with a known good flowmeter and it was found that the output would not go above 21.2%.The f102 knob was loose and rubbing on the mixer body and only one set screw was in the knob.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the last overhaul of the mixer found no non-conformities and the mixer passed all functional testing.User manual instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.

Event Description

During procedure, the perfusionist states the patient's blood started to turn black and they believe that they were not administering 100% oxygen.No patient injury occurred.

• Brand Name: SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G
• Type of Device: 3500 CP-G AIR OXYGEN MIXER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave,; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 9132146
• MDR Text Key: 195272452
• Report Number: 2020676-2019-00017
• 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
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500 CP-G
• Device Catalogue Number: 3500 CP-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2012
• 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