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

Model Number 60-01-04

Device Problem Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2020

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).Livanova initiated an investigation.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 priming.There was no patient involvement.

Manufacturer Narrative

H.10: the livanova field service representative that reached the facility was able to confirm the reported issue and by internal inspection of the drive unit he noticed that some components on motor control board were burnt.A loan device was provided to the customer.Based on the above facts,the most likely root cause of the reported issue was a defective motor control board.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: the affected device was investigated at the manufacturer site.Deviation could be reproduced.The root cause was a can bus interruption due to burnt component on the motor control board.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9981704
• MDR Text Key: 195921026
• Report Number: 9611109-2020-00273
• 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,Followup
• Report Date: 07/02/2020

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: 03/26/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 05/09/2020; 06/09/2020
• Supplement Dates FDA Received: 06/05/2020; 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1