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

Model Number 10-85-00

Device Problem Failure to Pump (1502)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device but he could not confirm the failure.The only way to reproduce the reported event was to have the pump cover opened.The analysis of the serial read-out of the pump revealed that possibly an over occluded pump may have led to the reported issue but this is not confirmed.The investigation is still ongoing.A review of the dhr did not identify any deviations or non-conformities relevant to 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 (b)(4) received a report that a s5 double head pump used for cardioplegia solution delivery did not start during procedure.The user restarted the pump but the issue persisted.The pump head was not turning but a flow value was displayed.The user turned off the complete s5 system and once restarted it, the pump was properly working.The procedure could be completed without further issues.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: further analysis on the serial read out revealed that the cardioplegia pump was linked to the master pump by the stop-link option.This means that every time the master pump is stopped by any alarm, the cardioplegia pump stops too.The cardioplegia pump got a stop due to the monitoring of the master pump (arterial pump).Right after this event, a general override was activated on the cardioplegia pump.When the general override is activated the external monitor is disabled for an unlimited period, thus all the alarm functions of the assigned devices are likewise stopped as the pump is stopped.The unit was put back in service.Basing on the above, it is possible to conclude that no hardware / software failure occurred and both pumps worked as expected.The root cause of the reported issue has been addressed back to a user error.

• 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: 9170473
• MDR Text Key: 197945854
• Report Number: 9611109-2019-00790
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• 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
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1