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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameS5 GAS BLENDER SYSTEM
Type of DeviceCONSOLE, 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 Key5897390
MDR Text Key52853085
Report Number9611109-2016-00565
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-40-57
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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