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

Model Number 60-02-50

Device Problems Device Operational Issue (2914); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).This event was reported to a (b)(4) field service representative while on site performing routine preventative maintenance.The service representative was unable to reproduce the reported malfunction during testing.The service representative noted that the flow probe and flow board during have been replaced in the past.The entire centrifugal pump system was replaced with a loaner unit.The loaner was functionally tested without issue and placed into service.The replaced unit was sent to sorin group usa for investigation.A follow-up report will be sent when the investigation is complete.

Event Description

(b)(4) received a report that the centrifugal pump system with tubing clamp experienced flow issues during a procedure.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The unit was requested and returned to livanova (b)(4) for further evaluation and investigation.Visual inspection of the unit notes evidence of minor spills on the pump control panel and minor physical damage on the bottom of the centrifuge.All cables and connector pins are in good condition.The s5 console for 4 pump was functionally tested on the s5 gold standard unit and operated without any deviation as intended.The reported error could not be reproduced during the investigation; root cause is unknown.A review of the dhr did not identify any manufacturing deviations or non-conformities relevant to the reported issue.Livanova has determined that a capa is not required, as there was no patient harm reported.Livanova will continue to monitor this issue for trends.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich,
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6357064
• MDR Text Key: 68374670
• Report Number: 9611109-2017-00166
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2008
• 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