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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2016
Event Type  malfunction  
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 (b)(4) received a user report that the blood of the patient became deoxygenated during a procedure that involved an s5 gas blender system. The gas blender was exchanged for a manual gas blender, however the patient oxygen levels did not significantly improve. The electronic gas blender was hooked back up to the patient. After 20 minutes it was possible to deliver oxygenated blood to the patient. There was no report of patient injury. The gas blender was returned to sorin group (b)(4) for further investigation. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a user report that the blood of the patient became deoxygenated during a procedure that involved an s5 gas blender system. The gas blender was exchanged for a manual gas blender, however the patient oxygen levels did not significantly improve. The electronic gas blender was hooked back up to the patient. After 20 minutes it was possible to deliver oxygenated blood to the patient. There was no report of patient injury.
 
Manufacturer Narrative
The manufacture date provided in the initial report, submitted on june 7, 2016, was incorrect. The correct manufacture date is: december 10, 2013.
 
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 received a user report that the blood of the patient became deoxygenated during a procedure that involved an s5 gas blender system. The gas blender was exchanged for a manual gas blender, however the patient oxygen levels did not significantly improve. The electronic gas blender was hooked back up to the patient. After 20 minutes it was possible to deliver oxygenated blood to the patient. 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, however the reported issue was confirmed during functional testing. The air valve and the mass-flow meter/controllers for air and o2 were replaced and a functional check and a new calibration was performed. Functional control and a technical safety inspection were carried out and no further issues were discovered. The device was cleaned and disinfected and 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
sorin group deutschland
munich, 80939
GM 80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5705091
MDR Text Key46760691
Report Number9611109-2016-00340
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeGM
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 05/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25-40-45
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/07/2016 Patient Sequence Number: 1
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