MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-20-60

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump 5.The incident occurred in (b)(6).The defective pump was returned to livanova (b)(4) for further investigation.A serial readout of the pump was performed and records of the reported issue could be identified.However, during the investigation it was not possible to reproduce the reported issue.Several intense testings were performed but the device worked according the specifications without a malfunction.Therefore a specific root cause for the reported issue could not be determined.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 5 switched off two times and displayed an error message during procedure.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) received further information which revealed that the firmware of the device was related to a known issue and could be the root cause for an unresponsive touch screen.This is a known issue and a corrective action is in progress for this issue.

• Brand Name: CENTRIFUGAL PUMP 5
• 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: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7258675
• MDR Text Key: 99992903
• Report Number: 9611109-2018-00092
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: 010403381790100611161128
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-20-60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1