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

Model Number 10-88-00

Device Problem Pumping Problem (3016)

Patient Problem Air Embolism (1697)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

Patient information: patient information was not provided.Livanova (b)(4) manufactures the s5 roller pump.The event occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.He inspected the device and was unable to reproduce the reported issue or identify any problems with the device.A pump serial readout was provided to livanova (b)(4) for analysis.No alarm, stop or warning regarding the bubble sensor was stored in the microcontroller of the arterial pump.Through follow up communication with the chief perfusionist of the center, livanova (b)(4) learned that the claimed air delivery to the patient occurred at the end of the surgery when the perfusionist was retrieving as much blood as possible from the arterial line.During the reported event, the perfusionist intentionally overrode all monitoring function in order to continue to run the pump and return as much blood as possible to the patient.In this condition it is likely that the operator was not able to stop the pump before the air was reaching the patient.Based on the retrieved information on the event, and the results of the inspection of the device and the readout of the pump, livanova (b)(4) concluded that the device worked according to specifications.Through follow up communications livanova (b)(4) learned that the patient is stable and will be transferred to a rehabilitation facility.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that during an extracorporeal circulation with an s5 roller pump air was delivered to the patient.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 89309 ; GM 89309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 89309 ; GM 89309
• Manufacturer Contact: njemile crawley ; 14401 w. 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8417843
• MDR Text Key: 138706470
• Report Number: 9611109-2019-00155
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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): Other