• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 02/17/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. Device has not yet been returned to sorin group (b)(4). 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 did not deliver the correct amount of oxygen during a procedure. There was no report of patient injury. The device has been requested for return to sorin group (b)(4) for investigation and repair. A follow-up report will be sent when the investigation is complete. Device requested, not yet returned.
 
Event Description
Sorin group (b)(4) received a report that the s5 gas blender system did not deliver the correct amount of oxygen during a procedure. There was no report of patient injury.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(4). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group received a report that the s5 gas blender system did not deliver the correct amount of oxygen during a procedure. There was no report of patient injury. A sorin group field service representative was dispatched to the facility to investigate. During testing, the service representative confirmed the reported issue and observed that no oxygen was being mixed in, though the flow was correct. There were no alarms. The device was replaced and the replacement unit was powered up. No further issues were observed. The replaced gas blender was returned to sorin group (b)(4) for further investigation. Visual inspection did not identify any defects or abnormalities. The unit was tested and the error was reproduced. Troubleshooting identified the mass-flow meter/controller to be causing the issue. The component was replaced and the unit was disinfected and cleaned. A test run was performed and no further issues were discovered. A functional check, technical safety inspection and calibration were carried out without issue. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5499492
MDR Text Key40302728
Report Number9611109-2016-00122
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
Report Date 02/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2016
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-