MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SRD S5 ERC TUBING CLAMP/500MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-60

Device Problems Difficult to Open or Close (2921); Noise, Audible (3273)

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

Event Date 03/09/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that the electrical remote-controlled tubing clamp (erc) is not working correctly during a procedure.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in united states.A livanova field service engineer was dispatched to the customer site and the erc was replaced.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

See initial report.

Manufacturer Narrative

Through follow-up communication livanova learned that the involved electrical remote-controlled tubing clamp (erc) was not sensing tubing and making squealing sounds when clamping and unclamping.As per device instructions for use, the issue that the tubing is not recognized it means that the clamping lever is in the ¿close¿ position.Simultaneously, an alert tone sounds at the scp system.Even in the case the clamp remains in closed position, it can always be manually opened.Automatic clamps devices are equipped with a handle aimed at the manual opening of the clamp releasing the engaged tube.Therefore, in case of undesired closure of the automatic clamps occurs, opening it is always possible to act on the handle to prompt perform a manual opening which is unlikely to cause or contribute to death or serious injury.Therefore, the event has been re-assessed as not reportable.Based on the review of similar complaints and according to device instructions for use, the "no tubing recognized" error message can be displayed when: - no tube is inserted into the clamp; - the wrong tube is inserted into the clamp.Regarding the noise issue and considering that the claimed clamp was manufactured in 2022, the wearing of the unit ball bearing can be ruled out and most likely the noise has been caused by residues of dried fluids on the shafts, which which obstruct the movements generated noise.

• Brand Name: SRD S5 ERC TUBING CLAMP/500MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; arvada
• 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: 16681779
• MDR Text Key: 312722092
• Report Number: 9611109-2023-00148
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)220531
• 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
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-05-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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