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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP 5 (CP5); CARDIOPULMONARY BYPASS PUMP SPEED CONTROL

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SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP 5 (CP5); CARDIOPULMONARY BYPASS PUMP SPEED CONTROL Back to Search Results
Model Number 60-01-04
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)(6) received a report that the disposable centrifugal pump head de-coupled from the cp5 centrifugal pump driver causing a loud noise during setup.There was no pt involvement.
 
Manufacturer Narrative
There was no pt involvement.Sorin group (b)(4) manufactures the sorin centrifugal pump.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
SORIN CENTRIFUGAL PUMP 5 (CP5)
Type of Device
CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
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, mgr
14401 west 65th way
arvada, CO 80004
3034676527
MDR Report Key3671943
MDR Text Key4340424
Report Number1718850-2014-00040
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K112225
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 02/03/2014
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 Number60-01-04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2014
Initial Date FDA Received02/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
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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