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

Model Number 48-40-00

Device Problems Decreased Pump Speed (1500); Increased Pump Speed (1501)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Livanova received report of a shaft angle encoder error message on a pump used on a s5 system.The error occurred during setup and there was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 system.The incident occurred in (b)(6).It is likely that the shaft angle encoder will be replaced.A service quotation has been sent to the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: complaints database analysis also revealed that no similar event since unit installation in 2008.No service activity has been scheduled yet for this device.However, based on investigation results of previous similar cases, the reported issue can be traced back to a defective shaft angle encoder due to wear.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event.If service activity will be performed on this device or any additional information is received, a supplemental report will be submitted.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15560521
• MDR Text Key: 306820073
• Report Number: 9611109-2022-00509
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2008
• 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