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

Model Number 10-88-00

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

Was no patient involvement.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 livanova field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and replaced the pump with a loaner device.The faulty device was returned to livanova (b)(4) for further investigation.The returned device was inspected and the reported issue was confirmed.A defective bearing was identified and it caused non-uniform movement of the bearings.The complete pump head was replaced and the device was cleaned, disinfected and tested without issue.A technical safety inspection was successully performed and the device was returned to the customer.The exact cause of the damaged bearing could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

Livanova (b)(4) received a report that the bearings of the s5 mast roller pump failed during priming.There was no patient involvement.

• 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: 6408292
• MDR Text Key: 70100173
• Report Number: 9611109-2017-00162
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/15/2017

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: 10-88-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• 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