MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 25-40-57

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

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).Sorin group (b)(4) received a report that an error message was displayed on the s5 gas blender system and the sorin s5 system panel during a procedure.The failures caused the flow to stop and the customer switched to a sechrist gas blender and continued the case without further issues.There was no patient injury.The unit was removed from service and sorin group (b)(4) has requested that the device be returned for investigation.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that an error message was displayed on the s5 gas blender system and the sorin s5 system panel during a procedure.The failures caused the flow to stop and the customer switched to a sechrist gas blender and continued the case without further issues.There was no patient injury.

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 an error message was displayed on the s5 gas blender system and the sorin s5 system panel during a procedure.The failures caused the flow to stop and the customer switched to a sechrist gas blender and continued the case without further issues.There was no patient injury.The complained gas blender was returned to sorin group (b)(4) for investigation.It was found during investigation that the issue is related to an s3 gas blender and not to an s5 gas blender.As the s3 gas blender is not marketed in the usa, this event has been determined to be non-reportable in the usa.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, 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: 5897390
• MDR Text Key: 52853085
• Report Number: 9611109-2016-00565
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-57
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2006
• 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