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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 Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2016
Event Type  No Answer Provided  
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 stopped working properly and the arterial blood started to turn a darker color. A backup gas blender was used to continue the procedure. There was no patient injury. 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 s5 gas blender system stopped working properly and the arterial blood started to turn a darker color. A backup gas blender was used to continue the procedure. There was no patient injury.
 
Manufacturer Narrative
(b)(4).
 
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 stopped working properly and the arterial blood started to turn a darker color. A backup gas blender was used to continue the procedure. There was no 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 could not be reproduced or confirmed during functional testing. The device was cleaned and disinfected and a calibration was performed. A subsequent test run did not identify any faults. A functional control and technical safety inspection were successfully performed and the unit was returned to the customer. 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.
 
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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 Key5757129
MDR Text Key48403120
Report Number9611109-2016-00424
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 06/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2016
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 Manufacturer07/25/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
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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