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

Model Number 48-30-00

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 system.The incident occurred in (b)(6).This report is filed on behalf of sorin group (b)(4).Sorin group received a report that during set-up the pump touch screen was unresponsive.There was no patient involvement.The investigation is on-going.A follow-up report will be submitted when the investigation is complete.

Event Description

Sorin group received a report that during set-up the pump touch screen was unresponsive.There was no patient involvement.

Manufacturer Narrative

There have been two field actions for this issue.The z-numbers are z-0956/0965-2011 and z-1149/1158-2012.(b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).A (b)(4) field service representative was dispatched to the facility to investigate.The service representative tested the unit and was able to reproduce the error.The faulty touch screen was replaced with a new led touch screen.The unit was functionally tested without issue and returned to service.Photos of the touch screen were taken and provided to (b)(4) for further analysis.It was confirmed that the touch screen falls under an existing root cause investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.This is a known issue for which a root cause investigation ((b)(4)) was initiated.Evaluated on site by (b)(4) technician.

• Brand Name: SORIN S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munchen D 809 39; GM D 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: 5088138
• MDR Text Key: 26259678
• Report Number: 9611109-2015-00361
• 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: Other
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 02/24/2017

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: 48-30-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0956/0965-2011
• Patient Sequence Number: 1