MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 ROLLER PU,P; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problems Device Inoperable (1663); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 roller pump.The incident occured in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the pump touchscreen was unresponsive during the procedure.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 roller pump.The event occurred in (b)(6).(b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative tested the device and was unable to reproduce the reported malfunction.Visual inspection identified build up on the gasket of the touch screen that could be caused by cleaning the screen with wipes.The service representative advised the customer to clean the touch screen with a dry cloth only.As a precaution, the touch screen was replaced.After service, it was confirmed by the perfusionist that the system worked within specifications.The customer kept the old touch screen.No further issues have been reported for this unit.As the issue was not reproduced and the customer kept the replaced touch screen, a root cause could not be 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.Device evaluated on site by livanova technician.

• Brand Name: S5 ROLLER PU,P
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindbergh strasse 25; munich D8093 9; GM D80939
• 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: 5001368
• MDR Text Key: 23165864
• Report Number: 9611109-2015-00287
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2007
• 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