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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA, INC. STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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SORIN GROUP USA, INC. STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-02-15
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem No Patient involvement (2648)
Event Date 01/27/2014
Event Type  Other  
Event Description
Sorin group (b)(4) received a report that the centrifugal pump stopped during set up.The issue was resolved by re-seating the cable connections and the procedure was completed with no further issues.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).The investigation is ongoing.A follow up report will be sent when the investigation is completed.
 
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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 USA, INC.
14401 west 65th way
arvada CO 80004
Manufacturer (Section G)
SORIN GROUP USA, INC.
14401 west 65th way
arvada CO 80004
Manufacturer Contact
cheri voorhees
14401 west 65th way
arvada, CO 80004
3034676527
MDR Report Key3671918
MDR Text Key4340371
Report Number1718850-2014-00031
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/27/2014
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? No
Device Operator Health Professional
Device Model Number60-02-15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2014
Initial Date FDA Received02/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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