MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G3; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 3500CP-G

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

User facility did not return the mixer to sechrist industries for inspection and testing.The user facility sent the mixer to their own off-site service provider to investigate and service the mixer.The results were that the alarm looked like the cap was out of place which caused the reed to be out of place or pushed back causing the mixer to not alarm when it should.The problem was corrected and mixer was calibrated, tested and is working and is back in service at the user facility.Note from reporter is " blender is mounted on a standard two wheel tank cart made for two e-tanks and is used to transport the patients from or to their room".Sechrist states that "at this time there is no evidence 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." user's manual for this mixer has warning statements - " risk is mitigated to the lowest reasonable level through labeling and/or instructions in the manual.Sechrist recommends completing performance verification prior to each clinical use.The verification should be conducted by qualified technical personnel.Constant attendance by qualified personnel is required whenever the device is in use.If the device should fail to perform per specification, it should be removed from use and evaluated by an authorized sechrist service technician.An oxygen analyzer and alarm are to be in-line downstream from the mixer as a secondary unit to alert the user to any issues." sechrist references incident (b)(4).

Event Description

During use with a patient, the device did not alarm when o2 or air gases were low.Also, seems to be leaking gas, as tanks are running out quickly.Blender is mounted on a standard two wheel tank cart made for two e tanks and is used to transport the patients from or to their room.No patient injury reported.

• Brand Name: SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G3
• Type of Device: OXYGENATOR, 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 avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225. la palma ave.; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 9225673
• MDR Text Key: 207982810
• Report Number: 2020676-2019-00019
• 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: 09/30/2019

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-G
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• 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