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

Model Number 60-02-50

Device Problem Complete Blockage (1094)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2018

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), usa.The defective part has been investigated.The described error could be reproduced.The origin of the failure is was a blocked mechanism, whereas the root cause of this blocked mechanism remails unknown.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that the knob on the centrifugal pump system was not operable anymore.The issue has been detected during the set-up.There was no patient involvement.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: njemile crawley ; 14401 w. 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8303826
• MDR Text Key: 134969650
• Report Number: 9611109-2019-00049
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-02-50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1