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

Model Number 60-03-75

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the cenrifugal pump console.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and could confirm the reported issue.He replaced the pressure module and the problem was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Livanova requested the part for further investigation but the customer retained the module and was not available to be returned.A defect of the pressure module led to the reported failure can be the most likely root cause.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

Livanova received a report that the error message " no com!" associated to the pressure module was displayed on a centrifugal pump console during setup.There was no patient involvement.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9514797
• MDR Text Key: 196751363
• Report Number: 9611109-2019-01000
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2010
• 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