MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	12-80-40
Medical Device Problem Codes	Calibration Problem (2890); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the essenz electrical venous occluder (evo).The incident occurred in (b)(6).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 an esssenz electrical venous occluder (evo) behaves erratically: it does not provide consistent clamping and occasionally opens or closes on it's own.The unit is in use at a perfusion school laboratory and not in a clinical setting.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the essenz electrical venous occluder (evo).The incident occurred in (b)(6).From follow-up communication, the following findings have been highlighted: a residual flow had been observed following the automatic clamp closure and opening, during the on-site visit, the clamp was checked by livanova field service technician and the issue was not reproduced.The clamp was found to work correctly without any hardware failure.Indeed, the issue was most likely due to a missing calibration of the clamp at the startup phase, and as a result the automatic clamp opening and closing would have led to the reduction of flow, observed by the customer.Consequently, the event can be evaluated as not reportable.Cf, 15 jul 2024: based on the information received, ra changes from reportable to not reportable.Indeed, the issue was most likely due to a calibration failure, only a residual flow was noted at low flow, and the issue occurred in demo conditions, which could be particular and different from those set during a real case on a patient.

• Brand Name: ESSENZ ELECTRICAL VENOUS OCCLUDER (EVO)
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 19575031
• Report Number: 9611109-2024-00268
• Device Sequence Number: 8409733
• Product Code: DXC
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)230324
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082344
• 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
• Report Date (Section B): 07/25/2024

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: 12-80-40
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2023
• 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