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	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 erc tubing clamp / 500mm.The incident occurred in new york.Livanova field service engineer replaced the erc with (60-05-60u sn:(b)(6)) to resolve the issue per guidelines, perform functional checks and all passed with positive results.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 a report about a erc device failed to working during procedure.There is no report of patient impact.
Additional Manufacturer Narrative
H10: a comprehensive review of the device's service history revealed that it was manufactured in 2018, and no similar events or concerning trends have been reported.During the on-site technical inspection, which confirmed the unit's failure, it was observed that it intermittently failed to open or close.Additionally, damage to the wire of the electronic remote control (erc) was noted.Considering all the gathered information, it cannot be dismissed that the instability in the connection between the erc and the s5 system may have been due to the damaged cable, likely resulting from rough handling by the user over time.This instability in the connection may have consequently caused the electronic clamp to respond inadequately.
Event or Problem Description
See initial report.

• 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: 18442536
• Report Number: 9611109-2024-00011
• Device Sequence Number: 6930166
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)180119
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 60-05-60
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 02/18/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 03/18/2024
• Date Device Manufactured: 01/25/2018
• 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