MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND ST CONTROL PANEL MRP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASSE

Model Number 28-95-85

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

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2015

Event Type  Other  

Manufacturer Narrative

There was no pt involvement.Sorin group (b)(4) manufactures the s5 control panel.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group perceived a report that the touch screen menu did not react.However, when the enter key was tapped, the menu appeared.There was no pt involvement.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 touch screen menu did not react.However, when the enter key was tapped, the menu appeared.There was no pt involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 control panel.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 menu of the s5 control panel did not react.However, when the enter key was tapped, the menu appeared.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.The service representative replaced the touch screen to resolve the issue.The replaced device was returned to sorin group deutschland for further investigation.The returned touch screen underwent a visual inspection and functional testing, however the reported issue was not confirmed or reproduced.The returned device was scrapped as a precaution.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced, a root cause was not determined and corrective actions were not identified.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: ST CONTROL PANEL MRP 85
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASSE
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghst. 25; munchen 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: 5015581
• MDR Text Key: 23614717
• Report Number: 9611109-2015-00298
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Followup
• Report Date: 07/22/2015

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: 28-95-85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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