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

Model Number 48-40-00

Device Problems Failure to Auto Stop (2938); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A serial readout was performed and was sent to livanova (b)(4) for evaluation.Inspection of the serial read out was unable to confirm the reported issue on the event date.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report that a s5 roller pump connected to the s5 system did not stop when the level fell below the level reservoir during a procedure.The customer confirmed that the level sensor was switched on and the pump was assigned correctly at the time of the event.However, the level symbol was not visible on the pump.The system was turned off and back on to resolve the issue.There was no report of patient injury.

Manufacturer Narrative

The reported device was not returned for investigation.However livanova (b)(4) performed an investigation by simulating the reported issue on a representative device from inventory.The reported failure could be confirmed only by performing the required set-up steps in an order that differs from the one indicated in the device instruction for use (ifu).The reported issue could not be replicated by following the instructions for use.Therefore as root cause could be determined the method used by customer, i.E.Not following the livanova ifu correctly.

• Brand Name: S5 SYSTEM
• 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: 6714061
• MDR Text Key: 80059697
• Report Number: 9611109-2017-00533
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/12/2018

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: 48-40-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2011
• 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