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

Model Number 60-02-50

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2019

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 error code.The technician suspects two possible cause for the reported issue: it is possible that the control panel of the other centrifugal pump system used on s5 system 48e00581 damaged the drive unit; it is also possible that installing the drive unit back onto 48e00582 has damaged the centrifugal pump system.A new processor board and a new motor control board have been ordered.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 system with tubing clamp used on the s5 system 48e00582 displayed an error code during priming.This happened after they experienced the same error code on another s5 system/ centrifugal pump system.The motor drive unit was installed from the first s5 system (48e00582) onto the second (48e00581) but the error code persisted.When the user returned to use the device back on 48e00582, the same error code appeared also on this s5 system.There was no patient involvement.

Manufacturer Narrative

H.10: the technician replaced the motor drive unit and the processor board and the issue persisted anyhow.The technician identified the root cause in a defective hall effect/index sensor.Since the unit was old manufactured in 2007 a loaner unit has been provided and the defective one will be scrapped.

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: 9250551
• MDR Text Key: 195736631
• Report Number: 9611109-2019-00857
• 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: 10/29/2019

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: 60-02-50
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1