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

Model Number 60-01-04

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump 5.The incident occurred in (b)(6), united states.A livanova field service representative was dispatched to the facility to investigate the device.The service representative was not able to confirm the reported issue.The affected part has been replaced on precaution.Functional verification testing was completed without further issues and the unit was returned to service.The affected part was returned to livanova deutschland for a detailed investigation.The investigator could reproduce the reported issue only once even though intensive testing.As the issue could be reproduced only once, a root cause could not be determined.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

Livanova (b)(4) received a report regarding an error about fault in motor controller of centrifugal pump one on a centrifugal pump 5 occured during procedure.There was no report of patient injury.

• 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: barbara galasso ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 8892632
• MDR Text Key: 175858543
• Report Number: 9611109-2019-00631
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: 010403381790094811160318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/14/2019

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: 60-01-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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