MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CP5 FLOW SENSOR; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 96-414-140

Device Problems Inaccurate Flow Rate (1249); Unable to Obtain Readings (1516)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that the knob of a centrifugal pump system with tubing clamp was not adjusting the flow in terms of rotation per minute (rpm), during setup.There was no patient involved.

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).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: through follow-up communication with livanova field service representative, it was learned that issue was with the flow sensor, not with the scp.In detail, flow sensor was not reading flow.Therefore, it was put out of use by the customer and replaced with another one by livanova technician.Subsequent functional verification testing was completed without issues and the unit was put to service.Flow sensor not reading the flow is always detectable before patient use, therefore the event has been re-assessed as not reportable.

Event Description

See initial report.

• Brand Name: CP5 FLOW SENSOR
• Type of Device: 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: 17434987
• MDR Text Key: 320779350
• Report Number: 9611109-2023-00370
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-414-140
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1