MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN S3 GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 24-40-00

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that s3 gas blender displayed an error message during a procedure.There was no patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 gas blender.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The s5 gas blender is not sold in the united states but a similar s5 gas blender which is sold in the united states.The 510k # for the s5 gas blender is k101046.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

(b)(4) manufactures the s3 gas blender.The event occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).A (b)(4) field service representative was dispatched to the facility to investigate.The service representative learned that the user completed the procedure by switching with o2 bottle.The service representative was able to reproduce the reported error.A loaner unit was provided to the customer and the faulty device was returned to (b)(4) for further investigation.During evaluation at (b)(4), the issue could not be reproduced.All tests performed were error-free.A test run and safety check were performed and the unit was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: SORIN S3 GAS BLENDER
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindbergh strasse 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 4564630
• MDR Text Key: 5561360
• Report Number: 9611109-2015-00037
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24-40-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• 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