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

Model Number	60-05-60
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the erc tubing clamp.The incident occurred in montpellier, france.The affected device was returned to livanova deutschland for repair.The reported issue was not reproduced.As per equipment maintenance intervention prevention the following parts were replaced: stator with sensor board, spindle complete with block, bearing ad groove ball bearing, both clamp boards.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received report that a s5 erc tubing clamp gave error message "arterial clamp defective" and open/close function buttons disappeared from the cp5 control panel during setup.There was no patient involvement.
Additional Manufacturer Narrative
H10: the device opening should be manually handled by the user unless an electro-mechanical failure is persistent and the clamp could block in a closed or open position.Since no malfunction/error was highlighted, a hardware failure can be ruled out.However, livanova field service representative's activity was performed after re-establishing the electrical contacts between the internal components of the arterial clamp, therefore, it cannot be excluded that a temporary loose connection between the clamp control board and the rotor may have led to the reported issue.
Event or Problem Description
See initial report.

• Brand Name: ERC TUBING CLAMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 15734926
• Report Number: 9611109-2022-00568
• Device Sequence Number: 20413456
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)170202
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 01/26/2023

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: 60-05-60
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2017
• 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