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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 Consequences Or Impact To Patient (2199)
Event Date 10/21/2014
Event Type  Other  
Event Description
Sorin group received a report that the centrifugal pump stopped during a procedure.There was no report of patient injury.
 
Manufacturer Narrative
Sorin group (b)(4) manufacturers the centrifugal pump system with tubing clamp.The incident occurred in (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 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, manager
14401 west 65th way
arvada, CO 80004
3034676527
MDR Report Key4385963
MDR Text Key16883771
Report Number1718850-2014-00463
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 11/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2014
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/14/2014
Date Device Manufactured01/01/2006
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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