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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-45
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Patient Involvement (2645)
Event Date 07/30/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate. The service representative was unable to confirm the reported issue. The device has been requested for return to livanova deutschland for further investigation. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that an s5 gas blender system experienced flow fluctuations during priming. There was no patient involvement.
 
Manufacturer Narrative
The gas blender system was returned to livanova (b)(4) for further investigation. The reported malfunction could not be confirmed or reproduced during the evaluation of the device. The device worked according the specification. The devise was disinfected and cleaned. Subsequent functional verification testing was completed without issues and the unit was returned to the customer.
 
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Brand NameS5 GAS BLENDER SYSTEM
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
MDR Report Key7809886
MDR Text Key118101719
Report Number9611109-2018-01179
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2018
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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