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

Model Number 60-02-60

Device Problem Communication or Transmission Problem (2896)

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

Event Date 05/23/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland 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 deutschland received a report that the arterial clamp had a cp5 timeout during procedure.Reportedly the clamp could be used normally after that.In addition, also a warning message appeared afterwards stating that the centrifugal pump was no longer monitored by the level monitoring function despite the level sensor was still active.Reportedly, the reported issues did not affect pump operation.There was no report of patient injury.

Manufacturer Narrative

Two pictures showing the error messages were provided, confirming the reported issue.A livanova field technician was dispatched to the customer facility the serial read out (real time device parameters and setting recording file) was retrieved and analyzed.The analysis of the cp5 control panel serial read-out revealed that the cp5 control panel had controller area network (can) interruptions, causing both of the displayed error messages.The analysis of the complaint database revealed that no further similar issues have been reported for this unit since installation in the field (2009).Based on all the above information, the root cause of the reported event was traced back to a defective hkr board located in the cp5 control panel (pn 90-305-620).No specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.

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
• MDR Report Key: 12009352
• MDR Text Key: 256504163
• Report Number: 9611109-2021-00328
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1