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

Model Number	60-05-00
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report that a s5 erc tubing clamp gave an error message "arterial clamp doesn't open / close" during setup.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in montpellier, france.The device is not available for return since customer will scrap it.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : device not available since customer will scrap the part.
Additional Manufacturer Narrative
H10: livanova learned that the erc tubing clamp gave error message "arterial clamp defective" and open/close function buttons disappeared from the cp5 control panel during setup.At the contrary of what reported initially, the device was no scrapped and 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
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: based on the field service activity performed, root cause of the reported event could be due to defective stator and clamp pcb boards.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 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: 15638232
• Report Number: 9611109-2022-00534
• Device Sequence Number: 6444405
• Product Code: DTQ
• UDI-Device Identifier: 04033817901037
• UDI-Public: 010403381790103711170202
• 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,Followup
• Report Date (Section B): 01/02/2023

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: 60-05-00
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 12/05/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/04/2022; 01/03/2023
• 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