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

Model Number 48-30-00

Device Problems Device Alarm System (1012); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

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 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.

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 Description

See initial.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8137172
• MDR Text Key: 129595602
• Report Number: 9611109-2018-01374
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: (01)04033817900887(11)170707
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 48-30-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1