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

Model Number	60-05-65
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 erc tubing clamp / 620mm gave a "arterial clamp defective" error message and the open/close key buttons disappeared from cp5 control unit display, therefore the clamp could not be controllable.The issue occurred during repair activity.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the s5 erc tubing clamp / 620mm.The incident occurred in coventry, united kingdom.Livanova field service representative testing of the device found signs of corrosion on the motor board pcb zkb and also that the stator was blocked inside the metal housing.In order to solve the issue, the following parts were replaced: - stator with sensor board - bearing scp - groove ball bearing - pcb control board (zkb 0204) - spindle complete with block - clamp housing rear subsequent functional verification testing was completed without further issues and the unit was returned to service.The read-out of the centrifugal pump (real-time device parameters and setting recording file) associated with the complained erc was provided and analysed.At 10.34 the panel stored the status of the clamp.At 11.11 a reboot of the cp5 panel is stored.It cannot be ruled out that a temporary cp5 timeout due to the reboot caused the clamp to close.A device service history review has been performed and identified that the unit was manufactured in 2021 and no other similar event has been reported, neither concerning trend has been identified.Based on above information, it cannot be ruled out that the issue was due to a failure of clamp electronic and mechanical components, possibly related to extensive exposure to liquid over time, e.G.During cleaning, that led to fluid ingress.

• Brand Name: S5 ERC TUBING CLAMP / 620MM
• Common Device Name: 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: 19687555
• Report Number: 9611109-2024-00294
• Device Sequence Number: 20863789
• Product Code: DTQ
• UDI-Device Identifier: 04033817901068
• UDI-Public: (01)04033817901068(11)211129
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-05-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown