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	Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(4).The read-out of the pump has been provided.The reported event is stored in the microcontroller shortly after the level alarm occurred.Results of red-out analysis revealed that the operator deactivated the level sensor function, thus the pump was no longer controlled by the level sensor and it could not start automatically again because the status of level alarm persisted.Indeed, the level alarm cannot be cleared until the level sensor detects fluid again but this is not possible if the user turns off the sensor.After a level sensor deactivation, the desired pump speed must be set manually.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 or Problem Description
Livanova (b)(4) received a report that a s5 mast roller pump stopped, following a level alarm, and it did not automatically restart after the level function deactivation.The event occurred during procedure.There was no report of patient injury.

• Brand Name: S5 MAST ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 89309 ; GM 89309
• MDR Report Key: 8443204
• Report Number: 9611109-2019-00181
• Device Sequence Number: 19555126
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: 010403381790047411151012
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 03/22/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1