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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-02-15
Device Problem Device Issue (2379)
Patient Problem No Patient Involvement (2645)
Event Date 05/03/2016
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Sorin group (b)(4) manufactures the sorin 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 (b)(4) received a report that the encoder of the sorin centrifugal pump system with tubing clamp did not work correctly during priming. There was no patient involvement. A sorin group field service representative was dispatched to the facility to investigate. The service representative confirmed that the knob for controlling the pump speed was no longer operational. Troubleshooting identified a loose fastener, which was secured with loctite. Functional tests and a test run did not identify any further issues. The investigation is ongoing. A follow-up report will be sent when the investigation is complete. Evaluated on site by sorin service rep.
 
Event Description
Sorin group (b)(4) received a report that the encoder of the sorin centrifugal pump system with tubing clamp did not work correctly during priming. There was no patient involvement.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp. The incident occurred in munich, germany. This medwatch report is filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the encoder of the sorin centrifugal pump system with tubing clamp did not work correctly during priming. There was no patient involvement. A sorin group field service representative confirmed the issue and identified a loose fastener, which was secured with loctite. Subsequent functional tests and a test run did not identify any further issues. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Sorin group (b)(4) has identified the root cause to be normal wear of the device. Sorin group (b)(4) will continue to monitor for trends related to this type of issue. Repaired on site by sorin service rep.
 
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Brand NameSORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
sorin group deutschland
munich, 80939
GM 80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5693563
MDR Text Key46361842
Report Number9611109-2016-00304
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-02-15
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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