MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500CP-G AIR/OXYGEN MIXER; OXYGENATOR,CARDIOPULOMARY BYPASS, PRODUCT CODE: DTX

Model Number 3500CP-G

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on the customer reported issue.Customer has been provided with a return authorization number to return the mixer to sechrist.Review of the device history for this mixer shows it was manufactured on 06/13/16 and no nonconformances were found in the manufacturing of the mixer.A review of the service history shows that the mixer had been returned to sechrist in 2018 for a recommended overhaul and no nonconformances were found during that overhaul.A supplemental will be submitted if more information is received on the incident.Incident (b)(4).

Event Description

Customer reported device is not supplying enough oxygen during clinical use and no patient injury reported.

Event Description

Supplemental medwatch required for product evaluation.

Manufacturer Narrative

Product inspection confirmed the reported issue and found there was damage to the 100-1000 ml/min flow meter knob and faceplate being shifted is indicative of being dropped.The fio2 is out of calibration and the alarm is out of calibration.Complaint review, for past twelve months, for similar devices, found no similar incidents.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.Manufacturer references incident # (b)(4).

• Brand Name: 3500CP-G AIR/OXYGEN MIXER
• Type of Device: OXYGENATOR,CARDIOPULOMARY BYPASS, PRODUCT CODE: DTX
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim, ca
• MDR Report Key: 9842947
• MDR Text Key: 207983078
• Report Number: 2020676-2020-00003
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1