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 Auto Stop (2938)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.(b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).Analysis of pump serial read-out revealed an error message stored in the micro-controller which confirmed the reported event.The reported error code can be due to: defective hall sensor in the pump head; defective motor control board.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.However, the motor control board was replaced as precaution.The most likely root cause is an intermittent failure of the motor control board.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that during the ecc, while administering cardioplegia dose, a s5 double head pump gave motor control failure error message.Reportedly, the pump did not stop but the customer improved the issue by turning the pump off and on.No further issues occurred during the surgery.The surgery was completed without problems.There was no report of patient injury.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 14043302
• MDR Text Key: 288802844
• Report Number: 9611109-2022-00161
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/06/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1