MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-88-60

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.On-site service not yet provided.

Event Description

Livanova (b)(4) received a report that roller head of the s5 mast roller pump overheated and displayed a "work load exceeded" error during a procedure.The pump was switched out to continue the procedure.There was no report of patient injury.

Manufacturer Narrative

Microbiological sampling identified a high level of contamination of the unit: mycobacteria could not be identified but its presence can not be excluded.The customer has planned to return the device to livanova (b)(4) for the deep disinfection procedure.The customer has stated that the cleaning and disinfection procedure has been performed according to the instructions for use (ifu) and that the heater-cooler device was placed inside the operating room during use.Corrective actions are in progress for this issue.

Manufacturer Narrative

A livanova service representative was dispatched to the facility to investigate.The service representative was able to reproduce the reported error during testing.It was reported that the pump became too hot to touch after 30 minutes of use.The mast roller pump was replaced to resolve the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The replaced pump was requested for investigation.However, the device was not made available and no investigation could be performed.

Event Description

See initial mdr.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, 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: 6411871
• MDR Text Key: 70176282
• Report Number: 9611109-2017-00180
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062396
• 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,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2011
• 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