MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SRD S5 ERC TUBING CLAMP/500MM; 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	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an arterial clamp is defective during a procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in new hyde park, new york.The livanova field service representative in charge could reproduce the error "arterial clamp defective" in the claimed clamp.The complained erc was a loaner erc and has been replaced another loaner erc under warranty.Functional verifications were performed, and tests were all conforming.Unit is back in 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.
Additional Manufacturer Narrative
H10: the affected part was returned to livanova deutschland for a detailed investigation.The investigator could not reproduce the reported issue: the device was tested several times and no error was found.Subsequent functional verification testing was completed without issues and the unit was returned to service.Since no malfunction/error was highlighted, a hardware failure can be ruled out.However, it cannot be excluded that a temporary loose connection between the clamp control board and the rotor may have led to the reported issue, which was fixed during service activity by re-establishing connections before functional test.

• Brand Name: SRD S5 ERC TUBING CLAMP/500MM
• 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: 15994225
• Report Number: 9611109-2022-00676
• Device Sequence Number: 12284340
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)220518
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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