MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH 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	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, during set up before case, the s5 erc tubing clamp displayed error of the motor is jammed and of no impulse transmission from the hall sensors (e106 and e109).There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the s5 erc tubing clamp.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: through follow-up communication livanova learned that customer decided to not repair the device.A device service history review has been performed and identified that the unit was manufactured in 2022 and no other similar event has been reported, neither concerning trend has been identified.According to livanova error code list document, the error code e106 indicates: - defective erc motor (the motor is jammed because of misalignment or foreign bodies).The error code e109, instead, indicates a missing impulse transmission from hall sensors at the stator of the erc, due to: - defective photoelectric barrier; - defective hall sensors at the stator of the erc, - defective motor.Taking into account that both errors have been displayed, the most likely root cause for the reported issue has been assigned to a defective erc motor.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: through follow-up communication livanova learned the involved erc serial number which was used during the surgery.Model/serial numbers have been added to the dedicated d.4 section.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.

• Brand Name: S5 ERC TUBING CLAMP / 500MM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 19593242
• Report Number: 9611109-2024-00270
• Device Sequence Number: 8470834
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)221027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/04/2024

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: 05/28/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 08/12/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/18/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2022
• 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