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

Model Number 60-03-75

Device Problems Device Sensing Problem (2917); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

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 Description

Livanova received a report that a centrifugal pump console speed control knob does not work.There was no report of patient injury.

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.

Event Description

See initial report.

• Brand Name: FLOW SENSOR
• Type of Device: 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
• MDR Text Key: 320795704
• Report Number: 9611109-2023-00384
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817901020
• UDI-Public: 010403381790102011151113
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K020571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-03-75
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1