MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH EVO CLAMP UNIT 50 MM - S5 ACCESSORY; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	12-80-10
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: through follow-up communication it was learned that after the error e1538 appeared, the display changed from showing the opening degree as a percentage, and the operation became impossible.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.Functionality of the device was inspected and no abnormality as found.Also the inside of the device was checked and no issue was found.Internal calibration of the occluder was carried out 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.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 evo tubing clamp.The incident occurred in 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, after priming was completed, a s5 evo tubing clamp displayed faulty rc_angle_error (e1538) and it can no longer be operated.After that, the device was turned it on and off several times and it improved.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: an anaysis of the complaints database did not reveal further events related to this unit.Based on the collected information and on technical intervention, a device hardware malfunction can be excluded as cause of the event.It cannot be ruled out that an incorrect tubing size / material could have contributed to the reported event.
Event or Problem Description
See initial report.

• Brand Name: EVO CLAMP UNIT 50 MM - S5 ACCESSORY
• 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: 19116023
• Report Number: 9611109-2024-00183
• Device Sequence Number: 17946041
• Product Code: DTQ
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)160412
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2024

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: 12-80-10
• Was Device Available for Evaluation?: No
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: Not provided; 05/31/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 04/19/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2016
• 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