MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-45

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Device has not been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the s5 gas blender system.The incident occured in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the s5 gas blender system displayed an error code.There was no patient injury reported.The device has been requested for return to sorin group (b)(4) for repair and investigation.A follow-up report will be sent when the investigation is complete.Device requested, not yet returned.

Event Description

Sorin group (b)(4) received a report that the s5 gas blender system displayed an error code.There was no patient injury reported.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 gas blender system displayed an error code.There was no patient injury reported.A sorin group field service representative was dispatched to the facility to investigate.The service representative was able to reproduce the reported issue.An alarm was displayed on the s5 console panel.The alarm could not be cleared and the gas blender was not usable.The unit was returned to sorin group (b)(4) for investigation and repair.Visual inspection of the returned unit at sorin group (b)(4) did not identify any defects or abnormalities.The unit was tested and the error was reproduced.The air valve, mass-flow meter/controller and dc/dc supply were replaced to resolve the issue.The device was disinfected and cleaned and a subsequent test run did not identify further issue.A functional control, technical safety inspection and calibration were performed without issue and the device was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5511429
• MDR Text Key: 40731420
• Report Number: 9611109-2016-00130
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

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: 25-40-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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