MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH FLOW SENSOR; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	60-03-75
Medical Device Problem Codes	Device Sensing Problem (2917); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump console.The incident occurred in (b)(6) california.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that a centrifugal pump console speed control knob does not work.There was no report of patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
During follow-up communication, it was reported that there was no malfunction with the control knob but with linked flow sensor: field service technician checked the unit by testing the knob, confirming that rpms were correctly read but fluctuated up-and-down.After switching flow sensor, the problem did not reappear.As reported, flow sensor was discarded and unit repaired was put back to service.Complaints database analysis revealed no similar event since unit installation in 2015.Based on all the above facts, the root cause of the reported issue has been traced back to a defective flow sensor most likely due to wearing of its electronics.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: FLOW SENSOR
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17480825
• Report Number: 9611109-2023-00384
• Device Sequence Number: 7465744
• Product Code: DTQ
• UDI-Device Identifier: 04033817901020
• UDI-Public: 010403381790102011151113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: IN
• PMA/510(K) Number: K020571
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023
• 2 Devices were Involved in the Event: 1 2

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: 60-03-75
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2015
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown