MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN C5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 58-00-00

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 05/15/2015

Event Type  Other  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin c5 system.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 display panel on the c5 for the roller pump became unresponsive during the procedure.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the display panel on the c5 for the roller pump became unresponsive during the procedure.There was no report of injury.

Manufacturer Narrative

Serial number: (b)(4).Device manufacture date (mm/dd/yyyy): 11/10/2013.Sorin group (b)(4) manufactures the sorin c5 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the display panel on the sorin c5 system became unresponsive during a procedure.There was no report of patient injury.The complained touch screen was replaced on-site and returned to sorin group (b)(4) for investigation.Visual inspection and a hardware analysis confirmed the reported issue and identified the root cause to be oxidation of the internal components as a result of fluid penetration into the touch screen.The investigation was completed on august 8, 2016, and the returned touch screen was scrapped.A review of the dhr did not identify any deviations or non-conformities relevant to the reported failure.No trend increase was identified for this type of issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: SORIN C5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; sorin group deutschland; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5060798
• MDR Text Key: 25292096
• Report Number: 9611109-2015-00329
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K093882
• 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: Followup
• Report Date: 08/03/2015

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: 58-00-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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