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

Model Number	10-88-00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported issue.Connections were checked and multiple test runs and extended test runs never failed.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Serial read out has been provided for further investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a s5 mast roller pump displayed an error message during procedure.There was no report of patient injury.
Additional Manufacturer Narrative
A serial read out of the pump memory has been provided to livanova deutschland for further investigation.During the evaluation the reported issue could be confirmed at the day of occurrence.After a bubble alarm, which has stopped the pump, the user switched off/on the pump without stopping to hand crank.This sequence of event has caused the reported error message.There were no hardware- or software alarms filed which have stopped the pump.The pump has worked as intended.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
Event or Problem Description
See initial.

• Brand Name: S5 MAST ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8077203
• Report Number: 9611109-2018-01336
• Device Sequence Number: 277072
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: 010403381790047411180613
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K062396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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
• Operator of Device: Health Professional
• Device Model Number: 10-88-00
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1