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

Model Number 60-03-00

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient information provided.Sorin group (b)(4) manufactures the stockert centrifugal pump console.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the touch screen of an scpc centrifugal pump console was defective.There was no report of patient injury.A sorin group service representative was dispatched to the facility to evaluate the issue.The service representative replaced the touch screen and performed functional tests.No further issues were reported.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 touch screen of an scpc centrifugal pump console was defective.There was no report of patient injury.

Manufacturer Narrative

(b)(4) manufactures the centrifugal pump console.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Inspection by the livanova service representative identified signs of moisture penetration into the touch screen.This was concluded to be the root cause of the reported issue, which was resolved by replacement of the complete display front panel.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova technician.

• Brand Name: STOCKERT 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: 5089589
• MDR Text Key: 26475599
• Report Number: 9611109-2015-00406
• 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: Followup
• Report Date: 03/08/2017

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2008
• 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