MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-95-85

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 control panel mrp 85.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova (b)(4) initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that when the s5 control panel mrp 85 pump speed is set to zero, the pump cover alarm sometimes sounds when the pump cover is opened and other times it does not.There was no patient involvement.

Manufacturer Narrative

H.10: through follow-up communication livanova deutschland retrieved several videos showing the pumps behaviour.An analysis of those videos has been performed and the event has been clarified.Initially, it was reported that when the pump is stopped,the alarm sometime sounds and sometime is not audible.No audible alarm shall be generated if the cover is opened when the pump is stopped.However, a warning is always visible on the pump display.If the speed knob is not exactly set to zero also an audible alarm should sound.It is very likely that this was the case.Based on the information received, livanova deutschland re-evaluated this case as non reportable since a warning was visible on the pump display with yellow icon even if the sound was not produced, which is the expected behaviour of the pump when it is not running and the cover is being opened.

Event Description

See initial report.

• Brand Name: S5 CONTROL PANEL MRP 85
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 9250274
• MDR Text Key: 195728928
• Report Number: 9611109-2019-00854
• Device Sequence Number: 1
• Product Code: DWB
• 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: 12/12/2019

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: 28-95-85
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1