MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-05-60

Device Problem Pumping Problem (3016)

Patient Problem Death (1802)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.He noticed that the collar of the shaft angle encoder was moving with knob.He tightened up the collar a bit to test unit and was still getting the reported error code.The technician opened the control panel and found out that the plastic housing on shaft angle had been broken.He replaced the encoder and solved the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Through follow-up communication livanova learned that the patient died eventually.Reportedly the outcome is not related to the reported malfunction.

Event Description

Livanova (b)(4) received a report that during a procedure an error code associated to a shaft angle encoder defective was displayed on the control panel of a centrifugal pump system with tubing clamp.This impacted the pump speed which could no longer be fully controlled by turning the knob on the control panel.Thus, the user hand-cranked the pump for about 30 minutes.Reportedly, during hand-crank, the ecmo circuit was being primed as a means to switch back over to machine support and possibly transport to the unit.

Manufacturer Narrative

H.10: the dissolved glued connection of the housing of the shaft encoder has been identified as the cause of the reported error message.Most likely, wear/aging of the component (manufacturing year 2014) and use conditions have led/contributed to the reported event.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10051378
• MDR Text Key: 195644779
• Report Number: 9611109-2020-00297
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K032213
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-05-60
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1