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

Model Number 60-02-50

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova deutschland 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 service representative was able to confirm the reported issue and traced the failure to a defective display panel.The technician replaced the panel to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The panel was requested back to livanova deutschland for further investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a centrifugal pump system with tubing clamp could not be controlled as the speed knob was blocked during procedure.There was no report of patient injury.

Event Description

See initial.

Manufacturer Narrative

H.10: the reported malfunction could be reproduced.It was not possible to turn the encoder, the shaft was stuck.Moreover, the knob and other accessories of the encoder were mechanically damaged.The cause of the event has been identified in a defective shaft angle encoder.

• 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: 8377685
• MDR Text Key: 138815144
• Report Number: 9611109-2019-00117
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817900993
• UDI-Public: (01)04033817900993(11)181219
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• 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 Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1