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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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SORIN GROUP DEUTSCHLAND STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-00
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem No Patient involvement (2648)
Event Date 10/30/2014
Event Type  Other  
Event Description
Sorin group (b)(4) received a report that the disposable pump head disconnected from the centrifugal pump driver during set up.There was no patient involvement.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
 
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Brand Name
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich
GM 
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich D 80 939
GM   D 80939
Manufacturer Contact
cheri voohrees, manager
14401 w. 65th way
arvada, CO 80004
3034676527
MDR Report Key4340618
MDR Text Key22058061
Report Number1718850-2014-00464
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K032213
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 11/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number60-01-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2014
Date Device Manufactured02/01/2008
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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