MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-01-04

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The drive unit was replaced with another, and the issue solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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) was giving a motor control failure error message during procedure.Reportedly the pump could not turn, and the user was not able to set rpm through the speed control knob.There was no report of patient injury.

Manufacturer Narrative

H10: deviation could be reproduced during the investigation.The root cause was a can interruption due to the defective processor board which will be replace in order to solve the problem.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10641153
• MDR Text Key: 210188804
• Report Number: 9611109-2020-00559
• Device Sequence Number: 1
• Product Code: DWA
• 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: 10/05/2020

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: 60-01-04
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1