MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500CP-G; RESPIRATORY MIXER, PRODUCT CODE: DTZ

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has not been returned for an evaluation.Should the unit be returned and evaluated a follow up report will be submitted.

Event Description

It was reported that respiratory mixer was part of their heart lung machine during procedure and when the respiratory mixer was used, the mixer did not give any output and the blood was not oxygenated.No reported injuries.

Manufacturer Narrative

Several attempts were made to retrieve the mixer for an evaluation and the product was not returned to sechrist.A device history review was performed (dhr) mixer 3500cp-g, serial number (b)(4), was manufactured on 10/23/2007.There is no indication that there were any relevant discrepancies during manufacturing.A review of the device history record (dhr) did not find any non-conformance that could cause or contribute to the reported issue.

• Brand Name: 3500CP-G
• Type of Device: RESPIRATORY MIXER, PRODUCT CODE: DTZ
• 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: victor arellano ; 4225 e. la palma avenue; anaheim, CA 92807
• MDR Report Key: 6603710
• MDR Text Key: 76395977
• Report Number: 2020676-2017-00014
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TZ
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1