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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-45
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Improper Flow or Infusion (2954)
Patient Problem No Patient Involvement (2645)
Event Date 09/26/2016
Event Type  malfunction  
Manufacturer Narrative
Sorin group (b)(4) manufactures the s5 gas blender system. This incident occurred in (b)(4). This medwatch report is being filed on behalf of sorin gorup (b)(4). Sorin group (b)(4) received a report that the flow values for the s5 gas blender system were too high and did not match the entered flow values. This issue was identified by a sorin group field service representative during maintenance. There was no patient involvement. The device has been requested for return to sorin group (b)(4) for investigation. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that the flow values for the s5 gas blender system were too high and did not match the entered flow values. This issue was identified by a sorin group field service representative during maintenance. There was no patient involvement.
 
Manufacturer Narrative
(b)(4) manufactures the s5 gas blender system. The event occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The involved device was returned to livanova (b)(4) for further investigation. During functional testing, the described error was reproduced and the issue was traced to a faulty mass-flow meter/controller. The component was replaced to resolve the issue. The device was disinfected and cleaned. A run test was performed without further issue and the unit was returned to the customer. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
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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)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6046868
MDR Text Key58066926
Report Number9611109-2016-00712
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeJA
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 05/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2016
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 Received04/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2011
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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