MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number SM000015

Device Problem Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The s5 control panel sm000015 is not distributed in the usa, but it is similar to the device 28-95-85, which is distributed in the usa (510(k) number: k071318).Livanova (b)(4) manufactures the s5 control panel mrp.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 issue and traced the failure to a faulty s5 control panel.The panel was replaced to resolve the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The replaced device was returned to livanova (b)(4) for further evaluation.The reported issue was confirmed during testing.Visual inspection identified bad soldering joints on an internal circuit bored, which caused the reported issue.The component was re-soldered and no further errors were detected.The board was discarded as a precaution and a new board was installed.Subsequent testing did not identify further issues and the device was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

Livanova (b)(4) received a report that an s5 mast roller pump could not be started using the s5 control panel mrp at the beginning of the procedure, though flow was displayed.Switching the pump did not resolve the issue.No patient was connected to the s5 system when the event occurred.

• Brand Name: S5 CONTROL PANEL MRP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 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: 6892261
• MDR Text Key: 89302262
• Report Number: 9611109-2017-00752
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/25/2017

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: SM000015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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