MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-01-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue, after testing the device for 45 minutes.Issue could be reproduced only after pinched the tubing on centrifugal pump system; following release of pinched tubing normal flow was reached.Centrifugal pump system worked properly.Subsequent functional verification testing was completed without issues 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.
Event or Problem Description
Livanova deutschland received a report that there was a flow dropping on centrifugal pump system when rotation per minute (rpm) was at its maximum.The issue occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
H10: complaints database analysis revealed no similar event since unit installation in 2016.Based on the collected data and since the event occurred only once at the customer site, a hardware failure of the centrifugal pump system as well as the flow sensor/module can be excluded.Most likely the root cause of the flow reduction was due to a specific condition related to procedure, and not device-related.
Event or Problem Description
See initial report.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Common Device Name: CONTROL, PUMP SPEED, 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: 16767219
• Report Number: 9611109-2023-00178
• Device Sequence Number: 3252797
• Product Code: DWA
• UDI-Device Identifier: 04033817900931
• UDI-Public: (01)04033817900931(11)160624
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K032213
• 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): 04/18/2023

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: 60-01-00
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2016
• 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