MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS MIXER MODEL 3500CP-G; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 3500CP-G

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned device found the unit will not increase fio2 from baseline reading.The unit fio2 is out of calibration and is stuck at around 21.3 fio2, the balance is affected due to the fio2 not increasing.Based on the age of the device, it is unlikely that a manufacturing non-conformity contributed to the reported complaint, and the 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.Mixers are multi-use, serviceable items.As such, it is anticipated that the units may occasionally require repair, and as part of standard care, the mixer should be inspected prior to use.If damage or functional issues are noted during these routine mixer inspections, the unit should not be put into use with a patient and should be reported to sechrist for servicing.Manufacturer reference file # (b)(4).

Event Description

Customer reported cannot measure the oxygen %, but when turned to 60, it "sits at 20".The issue was discovered at set-up.No patient incident was reported.

Event Description

Customer reported cannot measure the oxygen %, but when turned to 60, it "sits at 20".The issue was discovered at set-up.No patient incident was reported.

Manufacturer Narrative

Evaluation of the returned device found the unit will not increase fio2 from baseline reading.The unit fio2 is out of calibration and is stuck at around 21.3 fio2, the balance is affected due to the fio2 not increasing.Based on the age of the device, it is unlikely that a manufacturing non-conformity contributed to the reported complaint, and the 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.Mixers are multi-use, serviceable items.As such, it is anticipated that the units may occasionally require repair, and as part of standard care, the mixer should be inspected prior to use.If damage or functional issues are noted during these routine mixer inspections, the unit should not be put into use with a patient and should be reported to sechrist for servicing.Manufacturer reference file # (b)(4).

• Brand Name: SECHRIST AIR/OXYGEN GAS MIXER MODEL 3500CP-G
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; 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: 13053487
• MDR Text Key: 285393981
• Report Number: 2020676-2021-00036
• Device Sequence Number: 1
• Product Code: DTX
• 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 3500CP-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• 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