MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRICAL REMOTE-CONTROLLED 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	09/01/2023
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 tanabe, japan.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that a s5 erc tubing clamp / 500mm gave an error message related to a malfunction and the clamp mark on the s5 control panel disappeared.After checking the error display, the problem was resolved.The issue occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
Per the information provided by the livanova technician in charge, the issue could not be reproduced and it was asked the device to be shipped back to livanova for repair.In livanova, the device was cleaned and checked and the claimed problem was not reproduced as well.Functional verification checks were performed and passed positively.The unit returned to the customer.A device service history review has been performed and identified that the unit was manufactured in 2016 and no other complaints have been reported.The replaced parts have not been requested for a specific investigation for the following reasons: no short-term or long-term trends has been detected for the reported type of failure; reportedly, no patient impact occurred; in addition, a review of similar occurrences has been conducted and identified that the problem had been already investigated.Considering that the problem disappeared after being acknowledged during the procedure and no deviations of the clamp were found, the event can be considered as an isolated fault, whose root cause is unable to be determined.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Udi related data quality updates only.D1.Brand name has been corrected and updated in the dedicated section.
Event or Problem Description
See initial report.

• Brand Name: ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17850099
• Report Number: 9611109-2023-00476
• Device Sequence Number: 14272470
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)160711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/16/2024

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2023
• Supplement Date Received by Manufacturer: 03/03/2024; 08/08/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 03/28/2024; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2016
• 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