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

Model Number 48-40-00

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 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

The serial number will be forwarded when provided.The manufacturing date will be forwarded when provided.Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the touch screen monitors were not responsive.There was no patient injury.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 monitors were not responsive.There was no patient injury.

Manufacturer Narrative

Serial number: (b)(4).Device manufacture date (mm/dd/yyyy): 11/07/2014.(b)(4) manufactures the s5 console hlm.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported error.The displays were removed from the pumps and photos and videos of the frozen touch screens were provided to livanova (b)(4) for further analysis.Through analysis of the photos, it was concluded that liquid penetration was the cause of the reported issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.This is a known issue and corrective actions have already been implemented under capa (b)(4).Replacement touch screens were provided to the customer.Evaluated on site by livanova 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: 5088140
• MDR Text Key: 26259965
• Report Number: 9611109-2015-00364
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: AJ
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 03/02/2017

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: 48-40-00
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2014
• 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