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

Model Number 60-01-00

Device Problems Thermal Decomposition of Device (1071); Failure to Pump (1502)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier and weight not provided.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 pump did not start and after increasing the speed smoke came out of the engine during the procedure.There was no report of patient injury.

Manufacturer Narrative

The centrifugal pump system was returned to livanova (b)(4) for further investigation.During the evaluation it was found that a electronic component burned out on the board.During the investigation livanova (b)(4) determined that the burned out component was caused by incorrect user handling.

• 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: 7398538
• MDR Text Key: 104821869
• Report Number: 9611109-2018-00869
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• 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: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR