MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 60-03-75

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump console.(b)(4).The customer reported that the device is still in use.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device still in use; availability unk.

Event Description

Livanova (b)(4) received a report that the centrifugal pump console display suddenly went blue after the circuit was blood primed and ready to be put on the patient.The drive unit was still running.The user turned the console off and back on and the screen returned to normal.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to reproduce the reported issue.The touch screen and associated boards were replaced as suspected causes.The main power switch was also replaced as per customer's request.Subsequent functional testing did not identify further issues and the unit was returned to service.The defective components were returned to livanova usa, where initial visual inspection identified no evidence of spills or physical damage.The parts were returned to livanova (b)(4) for detailed investigation.The display was connected to the test bench: the device information was visible on the screen and the menu operation worked as expected.Finger/touch was detected as expected.The vertical and horizontal resistors were measured and no issues were identified.The display was opened and dried fluid was identified directly on the connector of the touch screen.This fluid was identified to be dried saline water and is the likely root cause of the reported issue.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 6635104
• MDR Text Key: 77623865
• Report Number: 9611109-2017-00458
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020571
• 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: 01/16/2018

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: 60-03-75
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 12/29/2017
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2014
• 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