MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Date of event is unknown.This information will be provided in a supplemental report if made available.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.The device was replaced and requested back to livanova deutschland for further investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a s5 roller pump suddenly turned off during priming.There was no patient involvement.

Manufacturer Narrative

During the investigation at the manufacturer site, the reported malfunction could be reproduced.The pump turned off by slightly moving the connector of the cable set.The cause of the reported malfunction could be identified in a defective connector.The replacement of the cable solved the issue.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8472416
• MDR Text Key: 140607417
• Report Number: 9611109-2019-00216
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)160621
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1