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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND S3 GASBLENDER 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 11/16/2015
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. 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)(6). A livanova field service representative was dispatched to the facility and was able to reproduce the error after two days of testing. Therefore the device was then sent to livanova (b)(4) for further investigation. During the investigation the reported failure could not be reproduced. Subsequent functional verification testing was completed without issues. As the issue could not be reproduced or confirmed, a root cause was not identified. A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
 
Event Description
Livanova (b)(4) received a report that the s3 gas blender system displays the error message after procedure. There was no report of patient injury.
 
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Brand NameS3 GASBLENDER SYSTEM
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindbergstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7326325
MDR Text Key102078750
Report Number9611109-2018-00191
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 03/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2018
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 Received11/16/2015
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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