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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-45
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. 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 alarmed and displayed an error code and an error message was displayed on the s5 system panel. A backup gas blender was used to continue the procedure. There was no report of patient injury. A sorin group field service representative was dispatched to investigate and confirmed the reported issue. The unit was removed from service and returned to sorin group (b)(4) for investigation and repair. The investigation is still on-going. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that the s5 gas blender system alarmed and displayed an error code and an error message was displayed on the s5 system panel. A backup gas blender was used to continue the procedure. There was no report of patient injury.
 
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 the s5 gas blender system alarmed and displayed an error code and an error message was displayed on the s5 system panel. A backup gas blender was used to continue the procedure. There was no report of patient injury. The gas blender was returned to sorin group (b)(4) for investigation. Visual inspection did not identify any defects or abnormalities. The reported issue was reproduced during functional testing. The error was traced to the air valve, which was replaced. A functional check and a new calibration were performed without issue. Functional control and technical safety inspection were successfully carried out. The device was cleaned and disinfected and returned to the customer. The 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.
 
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Brand NameS5 GAS BLENDER SYSTEM
Type of DeviceGAS 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 Key5734039
MDR Text Key47702454
Report Number9611109-2016-00413
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 05/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-40-45
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2013
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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