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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 01/21/2014
Event Type  Other  
Event Description
Sorin group received a report that a stockert centrifugal pump displayed an error during set up.There was no patient involvement.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the stockert centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the stockert centrifugal pump displayed an error during set up.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.While at the facility, the service representative confirmed the error and replaced the motor control and scp driver.The system was then run for 2-3 hours, no issues were found.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)
SORING 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 Key3644559
MDR Text Key17617739
Report Number1718850-2014-00028
Device Sequence Number1
Product Code DWA
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 01/21/2014
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 Number60-01-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/21/2014
Initial Date FDA Received02/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2006
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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