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

Model Number 60-01-00

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.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 service representative was not able to confirm the reported issue.The device worked according the specification.However, as the reported malfunction could be intermittent, the technician decided to replace the control board.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The board was requested back to livanova deutschland for further investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a centrifugal pump system with tubing clamp had an unstable rotation speed when the device was running on high rpm during procedure.There was no report of patient injury.

Manufacturer Narrative

The reported issue could not be reproduced, all tests were carried out without deviations.

Event Description

See initial.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8319717
• MDR Text Key: 138001201
• Report Number: 9611109-2019-00066
• 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: 04/02/2019

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
• Device Operator: Health Professional
• Device Model Number: 60-01-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1