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

Model Number 60-03-75

Device Problems No Display/Image (1183); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.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 control panel for the sorin centrifugal pump console displayed poor responsiveness during a procedure.The touch screen would only respond to strong pressure.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 and replaced the display.A functional check and trial run were completed without further issue and the unit was released to the customer.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that control panel for the sorin centrifugal pump console displayed poor responsiveness during a procedure.The touch screen would only respond to strong pressure.There was no report of patient injury.

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 control panel for the sorin centrifugal pump console displayed poor responsiveness during a procedure.The touch screen would only respond to strong pressure.There was no report of patient injury.A sorin group field service representative confirmed the issue on-site and replaced the display.The replaced display was returned to sorin group deutschland for further investigation.Through visual inspection and functional tests, sorin group deutschland was able to confirm the reported issue and identified the root cause to be fluid penetration (mix of dried blood and saline) 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.

• 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; sorin group deutschland; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5766901
• MDR Text Key: 48717088
• Report Number: 9611109-2016-00409
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K020571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

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 Number: 60-03-75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1