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

Model Number 60-03-00

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2016

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).A sorin group field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and performed a calibration test.The issue was resolved until the unit was restarted, at which point the touchscreen became unresponsive again.The touch screen was replaced and subsequent testing did not identify further issues.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 the touchscreen of the sorin centrifugal pump console became unresponsive during in-service.There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) performed an in house investigation on the returned part with the following results.The error could be reproduced.The cause of the fault was determined to be a touch screen defect.Root cause was found to be the presence of fluid between the ito layers.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

Customer complained of the touch screen not working.Service confirmation: 9000020603, scpc sn (b)(4) touch screen issues: the touch screen on scpc sn (b)(4) was not working properly; i tried to perform a screen calibration and started to work but when powering down the scpc and turning on, the touch screen would not work.Therefore the screen needed to be replaced.New touch screen was installed and all is working ok.Dev.Available with ref.(b)(4).Phone call with (b)(6) he wants to see the touch screen.Mdr: the service representative performed a calibration test, right after the touch-screen became responsive but after having switched-off and back on the sorin centrifugal pump console, the touch screen became once again unresponsive.

• Brand Name: SCPC 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): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6183209
• MDR Text Key: 62712781
• Report Number: 9611109-2016-00863
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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: 60-03-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: 02/01/2017
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1