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

Model Number 60-02-60

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the x.The incident occurred in x.A livanova field service representative was dispatched to the facility to investigate the device and he could not confirm the reported event.The device was working according to the specifications.The technician checked the operation record and connect data and found that, when the event occurred, the speed was at the minimum speed (1000 rpm ) and not zero.However, the device was replaced with another as precaution.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 the speed of a centrifugal pump 5 (cp5) became zero during procedure and no alarm was displayed.The flow rate dropped to zero triggering backflow alarms.The user turned the knob to restore the flow.After a while, the issue recurred and the flow rate was restored by turning the knob again.The procedure could be completed without further issues.There was no report of patient injury.

Manufacturer Narrative

H.10: further investigation of connect data revealed that the reduction of the cp5 flow was correctly triggered by a level sensor alarm and consequent arterial clamp closure.Based on the fact the the equipment worked as per specification and no malfunction occurred, the reported event has been re-assessed as non reportable.

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: 9355367
• MDR Text Key: 202999005
• Report Number: 9611109-2019-00907
• 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: 11/21/2019

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1