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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
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SORIN GROUP DEUTSCHLAND S5 GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-45
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem No Patient involvement (2648)
Event Type  Other  
Event Description
Sorin group (b)(4) received a report that the s5 gas blender displayed an error during set up.There was no pt involvement.
 
Manufacturer Narrative
There was no pt involvement.Sorin group (b)(4) manufactures the s5 gas blender.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is on-going.A follow-up report will be sent when the investigation is complete.
 
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Brand Name
S5 GAS BLENDER
Type of Device
GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich D 80 939
GM  D 80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich D 80 939
GM   D 80939
Manufacturer Contact
cheri voorhees, mgr, qual assur
14401 w. 65th way
arvada, CO 80004
3034676527
MDR Report Key3818227
MDR Text Key4503636
Report Number1718850-2014-00144
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Unknown
Remedial Action Other
Type of Report Initial
Report Date 04/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25-40-45
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2014
Initial Date FDA Received05/13/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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