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

Model Number 3500CP-G

Device Problem Increase in Pressure (1491)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Sechrist industries has made numerous attempts to obtain further information from the user facilty and the only information received from the initial reporter is that she is no longer in the patient safety coordinator role and that she has no further information other than what was reported on their medsun report sent to the fda. Review of the device history records for the mixer found it was built in 2013 and no non-conformances were found in the manufacturing of the mixer. Review of service history records for this serial number mixer found that this mixer has not been returned to sechrist for preventative maintenance as recommended in the user's manual. 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).

Event Description

Sechrist received a medsun mandatory and voluntary report form uf/importer report # (b)(4) in the regular mail from the department of health & human services, food and drug administration on december 09, 2019. The user facility report states " on 2 separate occasions with 2 different ecmo circuits, the ecmo circuit's seep flow meter (oxygen blender) increased without ecmo specialist's manipulation. No adverse event reported or patient involvement provided. Refer to medwatch report 2020676-2020-00002 / incident (b)(4) for the second report.

• Brand Name: 3500CP-G AIR/OXYGEN MIXER
• Type of Device: OXYGENATOR, CARDIPULMONARY 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 ave.; anaheim, CA 92807 ; 7145798909
• MDR Report Key: 9555999
• MDR Text Key: 208572541
• Report Number: 2020676-2020-00001
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/06/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3500CP-G
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse