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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

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SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number 60-03-00
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2016
Event Type  malfunction  
Manufacturer Narrative
Sorin group (b)(4) manufactures the sorin centrifugal pump console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the touch screen of the sorin centrifugal pump console became unresponsive post procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue.Visual inspection identified white liquid residue around the touch screen.The display was replaced and the unit was inspected and tested according to the manufacturer specifications.No further issues were noted and the unit was released to the customer.Sorin group (b)(4) determined the root cause to be fluid penetration into the touch screen.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
 
Event Description
Sorin group (b)(4) received a report that the touch screen of the sorin centrifugal pump console became unresponsive post procedure.There was no report of patient injury.
 
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Brand Name
SORIN CENTRIFUGAL PUMP CONSOLE
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM  80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM   80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5710903
MDR Text Key47137286
Report Number9611109-2016-00336
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 05/16/2016
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 Number60-03-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2016
Initial Date FDA Received06/09/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/19/2012
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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