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

Model Number 10-80-00

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).During communication with the biomedical engineer, it was reported that the internal evaluation of the device did not reproduce the reported issue.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device availability unknown.

Event Description

Livanova (b)(4) received a report that the s5 roller pump displayed an error message during setup.Patient impact has not been reported.

Manufacturer Narrative

The reported pump was returned to livanova (b)(4) for a detailed investigation.On visual inspection, multiple mechanical damages were observed on the pump and its cover.On functional testing, no deviations were observed on the pump.A test run with different speeds and different configurations was performed and no deviations could be detected.The error described could not be reproduced.The mechanical damages were probably as a result of transport and user mishandling.A review of the dhr could not identify any deviations or non-conformities relevant to the issue.

• Brand Name: S5 ROLLER PUMP
• 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; munich, CO 80004 ; 2812287260
• MDR Report Key: 6546341
• MDR Text Key: 74483647
• Report Number: 9611109-2017-00365
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• 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,Followup
• Report Date: 03/07/2018

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: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2010
• 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