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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 Problems Alarm Not Visible (1022); Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2015
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 system. The incident occurred in (b)(6). The device was returned to livanova (b)(4)for a detailed investigation and repair. A livanova service engineer was able to reproduce the reported error. The unit's front panel was replaced and a new calibration was performed. 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 the flow from a s3 gas blender system dropped suddenly to zero without an alarm during procedure. The customer was able to solve the issue with a restart of the device. 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
lindberghstrasse 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80939
GM 80939
Manufacturer Contact
joan caesar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7319944
MDR Text Key101969328
Report Number9611109-2018-00189
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeNL
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 03/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2018
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 Manufacturer11/27/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2004
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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