MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP CONSOLE

Model Number 60-03-75

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There was no report of patient injury.The involved device has not been returned to sorin group (b)(4).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)(6).Sorin group (b)(4) received a report that the display of the sorin centrifugal pump console became unresponsive during a procedure, however the pump continued to operate.There was no report of patient inquiry.A sorin group field service representative was dispatched to the facility to investigate.The service representative arrived at the facility to find that the unit had not been powered down since the issue occurred.The unit was rebooted and functioned properly.The issue was not reproduced after multiple reboots.A board was replaced as a precaution and the unit was put back into service.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) receieved a report that the display of the sorin centrifugal pump console became unresponsive during a procedure, however the pump continued to operate.There was no report of patient inquiry.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump console.The incident occurred in (b)(4) this medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the display of the sorin centrifugal pump console became unresponsive during a procedure, however the pump continued to operate.There was no report of patient inquiry.A sorin group field service representative replaced a pcb board as a precaution and the unit was put back into service.The replaced board was returned to sorin group usa for evaluation, where it underwent visual inspection and functional testing.The visual inspection did not identify any abnormalities or defects.The board was placed in a test scpc unit and tested for 30 minutes.No faults were produced and the device functioned as expected.The reported issue could not be duplicated.As the issue was not reproduced, a root cause was not determined and corrective actions were not identified.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 this type of issue for trends.Evaluated by sorin group usa.

• Brand Name: SORIN CENTRIFUGAL PUMP CONSOLE
• Type of Device: SORIN CENTRIFUGAL PUMP CONSOLE
• 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 Key: 5546228
• MDR Text Key: 41821773
• Report Number: 9611109-2016-00214
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/10/2016

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: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1