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

Model Number 48-40-00Z

Device Problem Pumping Problem (3016)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 pump gave a 'motor monitoring /control failed' error message during procedure.Pump was working and the customer could clear the error message, but it returned every 15 minutes.There was no patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 pump.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

A livanova field service engineer was dispatched to the customer site and was able to duplicate issue.To solve the issue, pump head and hkr board were replaced and all system flashed to be compatible.The device was tested and returned to 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.

• Brand Name: S5 SYSTEM PRO VERSION
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 18986325
• MDR Text Key: 339337504
• Report Number: 9611109-2024-00153
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817902676
• UDI-Public: (01)04033817902676(11)230321
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00Z
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2023
• 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