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

Model Number	48-30-00
Medical Device Problem Codes	Device Alarm System (1012); Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
Event or Problem Description
Livanova (b)(4) received a report that a s5 system alarmed without warning massages and that a pump stopped during procedure.There was no report of patient injury.
Additional Manufacturer Narrative
Through further provided information livanova deutschland determined that the reported issue will now considered as not reportable.As a pump stop which was initiated on purpose during a demonstration/training and a following error which was not displayed on the central display is not likely to result in death or serious injury.
Event or Problem Description
See initial.

• Brand Name: S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8137172
• Report Number: 9611109-2018-01374
• Device Sequence Number: 199153
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: (01)04033817900887(11)170707
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• 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): 05/02/2019

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: 48-30-00
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1