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

Model Number 60-01-00

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).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 the centrifugal pump console displayed an error message and stopped the pump during a procedure.The perfusionist used the hand crank and the pump was replaced.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) received the information that the initial provided device information were incorrect.The correct device information are: centrifugal pump system with tubing clamp, 60-01-00, (b)(4).As the device information have changed the manufacturing date was changed.(29.10.2009).Through follow-up communication with the customer livanova (b)(4) learned that the customer discovered some blood clotting in the revolution cone that may have been the cause for the cone stopping.Further the customer reported that he is unsure if the pump has really stopped.However the device was requested back to livanova (b)(4) for further investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

The device was returned to livanova (b)(4) for further investigation.The device was intensively tested but the reported issue could not be reproduced or confirmed.The device worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.

Event Description

See initial report.

• 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: 7231789
• MDR Text Key: 98857816
• Report Number: 9611109-2018-00078
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K020571
• 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,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1