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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND S3 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-00
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
The gas blender system 25-40-00 is not distributed in the usa, but it is similar to gas blender system 25-40-45, which is distributed in the usa (510(k) number: k052601). This event was initially considered to be non-reportable. However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable. This report is being filed as part of a retrospective review conducted in response to this new decision. Livanova (b)(4) manufactures the s3 gas blender system. The incident occurred in (b)(4). Livanova requested the device for detailed investigation and repair. During the investigation it was possible to reproduce the reported failure. The device was leaking and deviations in the values were detected. The root cause could be traced back to several defective components. Therefore the measure bridge, a front panel and an eprom were replaced to resolve the reported issue. Subsequent functional verification testing was completed without further issues and the unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
Event Description
Livanova (b)(4) received a report that according the user the s3 gas blender system intermittently shows an error message after procedure. There was no report of patient injury.
 
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Brand NameS3 GAS BLENDER SYSTEM
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
Manufacturer Contact
joan caesar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7330284
MDR Text Key102217944
Report Number9611109-2018-00203
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 03/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-40-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2016
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 Manufactured05/25/2000
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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