MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-95-80

Device Problems Loss of Power (1475); Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 control panel mrp.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report that an s5 control panel mrp lost power during priming.This power loss led to a stop of the mast roller pump.The customer restarted the s5 system to resolve the reported issue.However, the reported failure recurred when switching to another device.There was no patient involvement.

Manufacturer Narrative

The mast pump and processor board were returned to livanova (b)(4) for further investigation.The devices were intensively tested without finding malfunctions.The devices worked according to the specification.As the issue was not reproduced or confirmed, a root cause could not be identified.

• Brand Name: S5 CONTROL PANEL MRP 150/85
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7728983
• MDR Text Key: 115368516
• Report Number: 9611109-2018-01113
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900818
• UDI-Public: 010403381790081811161027
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

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: 28-95-80
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1