MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ERC TUBING CLAMP / 620MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-65

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Livanova initiated and investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

During the setup, the arterial line clamp error was displayed in the lower right corner of the system panel.The customer turned off the arterial line clamp.

Manufacturer Narrative

H.10: the livanova field service representative that reached the facility was able to confirm the reported issue.He replaced the clamp with another one.The device was requested for further investigation at the manufacturer site.The problem could be confirmed.The clamp was opened and corrosion on the rotor and dried blood, especially on the ball bearing, were visible.Therefore, the reported issue was due to the corroded bearing damaged by a blood leakage.

Event Description

See initial report.

• Brand Name: S5 ERC TUBING CLAMP / 620MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• MDR Report Key: 9526247
• MDR Text Key: 196443995
• Report Number: 9611109-2019-01010
• Device Sequence Number: 1
• Product Code: DTQ
• 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
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 60-05-65
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Patient Sequence Number: 1