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

Model Number 25-40-45

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Device has not yet 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 did not deliver the correct amount of oxygen during a procedure.There was no report of patient injury.The device has been requested for return to sorin group (b)(4) for investigation and repair.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 did not deliver the correct amount of oxygen during a procedure.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(4).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 gas blender system did not deliver the correct amount of oxygen during a procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.During testing, the service representative confirmed the reported issue and observed that no oxygen was being mixed in, though the flow was correct.There were no alarms.The device was replaced and the replacement unit was powered up.No further issues were observed.The replaced gas blender was returned to sorin group (b)(4) for further investigation.Visual inspection did not identify any defects or abnormalities.The unit was tested and the error was reproduced.Troubleshooting identified the mass-flow meter/controller to be causing the issue.The component was replaced and the unit was disinfected and cleaned.A test run was performed and no further issues were discovered.A functional check, technical safety inspection and calibration were carried out without issue.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: 5499492
• MDR Text Key: 40302728
• Report Number: 9611109-2016-00122
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• 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
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• 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