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

Model Number 10-85-00

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 double head pump.The incident occurred in (b)(6).A livanova field service representative investigated the device and could not reproduce the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a s5 double head pump used for cardioplegia delivery stopped once during priming and then during procedure.Reportedly, control display icon of the cardioplegia pump was lit in red and then the display cut off.The pump was replaced and procedure completed.There was no report of patient injury.

Manufacturer Narrative

H10: field service technician dispatched to the facility did not reproduce the issue.It was found that the processor board was the old version and was then replaced with a new one.All functional tests positively passed and the unit was put back into service.Serial readout of the involved pump was analyzed and revealed a system can bus interruption.Machine underwent annual maintenance and software update before the failure occurred.It cannot be ruled out that sw interference/incompatibility may have led to the reported issue.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: further analysis revealed that the root cause of the event is traceable to defective electronic circuit boards of the pump.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11176801
• MDR Text Key: 227015589
• Report Number: 9611109-2021-00026
• 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,Followup
• Report Date: 02/12/2021

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: 10-85-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/15/2021; 02/09/2021
• Supplement Dates FDA Received: 02/12/2021; 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1