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

Model Number	25-28-67
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/24/2016
Additional Manufacturer Narrative
There was no patient involvement.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).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The gas blender has been returned to sorin group (b)(4) for investigation.A follow-up will be sent when the investigation is complete.
Event or Problem Description
Sorin group (b)(4) received a report that the s5 gas blender system displayed an error code during installation.There was no patient injury reported.
Additional Manufacturer Narrative
The model number provided in the initial report (25-40-45) was incorrect.The correct model number is 25-28-67.
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The device was returned to livanova for further investigation.The described error could be reproduced.It was discovered that there was a loose plug connection at the co2 valve.The parts were replaced.The unit was disinfected and cleaned.Preventative maintenance was performed and the unit function properly without any further issue.

• Brand Name: S5 GAS BLENDER SYSTEM
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• MDR Report Key: 6191920
• Report Number: 9611109-2016-00888
• Device Sequence Number: 13672196
• Product Code: DTX
• UDI-Device Identifier: 04033817900757
• UDI-Public: 010403381790075711161107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2017

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
• Operator of Device: Health Professional
• Device Model Number: 25-28-67
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: Not provided; 09/28/2017
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 12/21/2016; 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1