MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH CENTRIFUGAL PUMP PLUS SYSTEM ( SCP ); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-00-50

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump plus system scp.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate but he could not confirm the reported issue.However, he replaced the flow control board.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The part was requested back to the manufacturer site for further investigation and no failure could be detected.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 display of the flow sensor on a centrifugal pump plus system (scp) was not showing the flow value during priming.There was no patient involvement.

Manufacturer Narrative

H.10: investigation results revealed that the reported failure does not stop or modify the pump flow.The flow rate can still be controlled with the knob and rpm can be estimated by the leds around it.Thus, the event is not likely to contribute to death or serious injury and based on this it has been re-evaluated as non reportable.

Event Description

See initial.

• Brand Name: CENTRIFUGAL PUMP PLUS SYSTEM ( SCP )
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9514780
• MDR Text Key: 196430282
• Report Number: 9611109-2019-00993
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K091008
• 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: 12/23/2019

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: 60-00-50
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1