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

Model Number 60-02-60

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in athens, georgia.The customer is going to purchase another drive unit.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a centrifugal pump cp5 gave a motor control failure error message during procedure.There was no patient injury.

Manufacturer Narrative

The unit was manufactured in 2014 and according to the analysis of the complaints database no similar events have been reported in the past.The equipment of this center is serviced by the hospital biomed and therefore no service activity by an authorized livanova field service technician was requested.Through a follow up communication it was learnt that the error code associated to the reported motor control failure was associated to a defective motor controller board located in the drive unit.For this reason, a new drive unit was purchased by the customer as reported in the initial report.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15174861
• MDR Text Key: 297899294
• Report Number: 9611109-2022-00396
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1