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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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SORIN GROUP DEUTSCHLAND STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-00-55
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 01/27/2014
Event Type  Other  
Event Description
Sorin group (b)(4) received a report that the flow rates of the centrifugal pump exceeded the set value while during a procedure.There was no report of pt injury.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the scp plus system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the flow rate of the centrifugal pump exceeded the set value while using during a procedure.There was no report of pt injury.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 PLUS SYSTEM (SCP PLUS)
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 Key3688143
MDR Text Key4243588
Report Number1718850-2014-00054
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K091008
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 02/05/2014
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 Number60-00-55
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/05/2014
Initial Date FDA Received03/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2009
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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