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

Model Number 10-80-00

Device Problem Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 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 varilock clamp.Subsequent functional verification testing was completed without issue and the unit was returned to service.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device has not been returned.

Event Description

Livanova (b)(4) received a report that varilock guide of the s5 roller pump broke during maintenance.There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).The claimed variolock clamp was returned to livanova usa for further inspection.Evidence of spills have been identified.Moreover, a pin was identified to be missing and it allowed the arm to sit higher than intended when locked in place, and to come off when unlocked.A photo of the defective variolock clamp was sent to livanova (b)(4) for further investigation.The variolock clamp was of an old design pattern.As corrective action, a change order has already been implemented.A review of the dhr could not identify any deviations or non-conformities relevant to the issue.

• Brand Name: S5 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: 6490044
• MDR Text Key: 72794820
• Report Number: 9611109-2017-00301
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• 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: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2012
• 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