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

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Model and serial numbers are unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).Further information in order to clarify the reported event has been requested.The investigation is in progress.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) displayed two alarms at the power up associated to a cp5 timeout and to the arterial clamp not connected/failed.Reportedly, also an error message associated to a venous clamp occurred.The user tried to solve the issue by rebooting the e/p pack of the s5 system where the cp5 was used on.Reportedly, despite error messages persisting on the screen, the device could be used to complete the operation without problems.There was no report of patient injury.

Manufacturer Narrative

H.10: through follow up communication livanova learned that the technician was not able to reproduce the reported issue and no problems were detected.The device was put back into service.Based on that it can not be ruled out that the most likely root cause of the reported issue is a user error during set-up.

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: 9944099
• MDR Text Key: 197330264
• Report Number: 9611109-2020-00244
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1