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

Model Number 60-02-50

Device Problems Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) 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 service representative was able to confirm the reported issue and traced the failure to a defective display panel.The technician replaced the panel to resolve the reported issue.Subsequent functional verification testing was completed without further 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.Device not returned.

Event Description

Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp could not zero the flow and did not show the correct flow amount intermittently during procedure.Patient information was not provided.

Manufacturer Narrative

The replaced device was returned to livanova (b)(4) for further investigation.During evaluation, the reported issue could be confirmed.The root cause for the reported issue was identified to be a faulty flow board.The customer has requested that the device not be repaired and the unit was scrapped.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7319955
• MDR Text Key: 101987508
• Report Number: 9611109-2018-00190
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-50
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1