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

Model Number 10-80-00

Device Problem Device Operational Issue (2914)

Patient Problems Air Embolism (1697); Death (1802)

Event Date 10/06/2017

Event Type  Death  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 roller pump.The event 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 performed a technical safety inspection and was unable to reproduce the reported issue or identify any problems with the device.A serial readout was performed and was provided to livanova deutschland for analysis.Analysis of the serial readout did not identify any hardware or software failures saved in the micro-controller.The readout did record a bubble alarm and subsequent pump stop, which is intended use of the device.Following this alarm, the bubble module was turned off by the user.Based on the readout, livanova (b)(4) concluded that the pump worked according to specification.Multiple attempts have been made to gather additional information about the malfunction from the customer.However, no additional information has been received at this time.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.Evaluated on site by livanova technician.

Event Description

Livanova (b)(4) received a report that an s5 roller pump malfunctioned and air was delivered to a patient during a procedure.The patient expired.The initial reporter is unsure if an error message appeared and could not clarify the nature of the malfunction.

• 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 80004 ; 2812287260
• MDR Report Key: 7009608
• MDR Text Key: 91337663
• Report Number: 9611109-2017-00902
• 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
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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
• Patient Outcome(s): Death