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

Model Number 60-02-15

Device Problem Partial Blockage (1065)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4), united states.There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(4), united states.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected parts have been asked to livanova (b)(4) for a detailed investigation.Corrective actions are in progress for this issue.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 speed of a centrifugal pump system with tubing clamp could not be adjusted any more during in-service.There was no patient involvement.

Manufacturer Narrative

Deviation could be reproduced during the investigation at the manufacturer site.The shaft encoder was stuck.

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: 8873333
• MDR Text Key: 162128961
• Report Number: 9611109-2019-00611
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817900986
• UDI-Public: (01)04033817900986(11)181105
• Combination Product (y/n): N
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-15
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1