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

Model Number 3500CP-G

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned device found the unit was missing the "general warning label", "ce label", "eu label", "read operators manual label" and manufacture's information printed on the side of the device.The unit was tested and met functional specifications.Internal investigation determined that an operator oversight contributed to the missing labels and capa (b)(4) was initiated to address the issue.Historical data found this is the first report of this type.Instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.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 reference file # (b)(4).

Event Description

Unit was missing the "general warning label", "ce label", "eu label", "read operators manual label" and manufacture's information printed on the side.This was discovered, by the distributor, prior to shipping and no patient or caregiver incident was reported.

• Brand Name: 3500CP-G AIR/OXYGEN MIXER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS, PRODUCT CODE: DTX
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim, ca
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim, ca
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim, ca ; 5798309
• MDR Report Key: 10329239
• MDR Text Key: 205356387
• Report Number: 2020676-2020-00008
• 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: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• 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: 07/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1