MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).The device has been requested for return to livanova (b)(4) for investigation.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.

Event Description

Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) displayed an error message and lost power several times during a procedure.The customer rebooted the device, which initially seemed to resolve the issue.However, after some time, the reported issue recurred.The customer replaced the device to continue the procedure.There was no report of patient injury.

Manufacturer Narrative

The device was returned to livanova (b)(4) for further investigation.Evaluation of the returned unit was unable to reproduce the reported issue.No issues were noted during visual inspection, and functional testing, including testing at various speeds, identified no issue.The device functioned according the specification.A serial readout was performed could not identify any issues on the reported event date.The unit was tested in a climate chamber at varying temperatures and humidity for 16 hours and no deviations were noted.As the issue could not be reproduced, a root cause was not identified.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7597219
• MDR Text Key: 111013678
• Report Number: 9611109-2018-01041
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: 010403381790100611170530
• Combination Product (y/n): N
• PMA/PMN Number: K112225
• 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: 07/20/2018

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: 60-02-60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1