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 Patient Involvement (2645)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

Device has been requested, but 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 an error message was displayed on the hlm system panel during priming.The s5 gas blender system was disconnected from the hlm and the error message was no longer displayed.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate and was able to confirm the reported error.Visual inspection revealed extensive corrosion on the gas blender casing and around the electrical plug and multiple other connections.The unit was replaced and subsequent functional checks found no further issues.The device has been requested for return to sorin group (b)(4) for investigation.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the an error message was displayed on the hlm system panel during priming.The s5 gas blender system was disconnected from the hlm and the error message was no longer displayed.There was no patient involvement.

Manufacturer Narrative

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).The complained gas blender was returned to sorin group (b)(4) for investigation.Visual inspection did not identify any defects or abnormalities and functional testing was unable to reproduce the reported issue.The device worked within specification.A functional check and a new calibration was performed, and functional control and a technical safety inspection were carried out successfully.The device was cleaned and disinfected and returned to the customer.As the issue could not be reproduced, a root cause could not be determined and corrective actions were not identified.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: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5645680
• MDR Text Key: 44888950
• Report Number: 9611109-2016-00291
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• 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: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2007
• 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