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

Model Number 60-05-40

Device Problem Difficult to Open or Close (2921)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in usa.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that, during a prcedure, an erc malfunction was reported.There is no report of any patient injury.

Manufacturer Narrative

H10: a livanova field service representative was dispatched to the facility to investigate the device: the erc tubing clamp was working properly.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H10: according to sap installed base analysis for involved customer, possible erc affected could be model 60-05-40, serial number (b)(6).Model and serial number have been added to the dedicated d.4 section.Based on technical intervention carried out, a hardware malfunction with the clamp can be ruled out.Therefore, it cannot be excluded that the reported event could have been caused by an incorrect set system by the user.

• 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
• 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: 18273543
• MDR Text Key: 329826316
• Report Number: 9611109-2023-00620
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-05-40
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2006
• 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