MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-60-00

Device Problem Pumping Problem (3016)

Patient Problem Death (1802)

Event Date 05/04/2017

Event Type  Death  

Manufacturer Narrative

Date of death has not been provided.This information will be submitted in a supplemental report if made available.Livanova (b)(4) manufactures the s3 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 was informed that the cause of death may have been air delivery to the brain.The service representative was unable to reproduce the reported fault during testing; the pump would not produce any movement when at 0 lpm.The boards and the ribbon cable inside the pump were reseated.The occlusion was tested and no issues were noted.All tests were passed.The speed potentiometer and collar were replaced as a precaution and the position of the s3 roller pump was switched with the backup arterial pump at the perfusionist's request.Preventive maintenance was performed on the entire system and all tests passed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 not returned.

Event Description

Livanova (b)(4) received a report that the s3 roller pump continued to pump slightly during priming, though the speed knob was turned to 0.0 lpm.The perfusionist decided to use the device for the operation.Air was detected and cleared from the prime line before the patient went onto bypass.The patient died after surgery.

Manufacturer Narrative

The age at the time of the event provided in the initial report, submitted (b)(6) 2017, was incorrect.The correct patient age is (b)(6) years.Date of death: (b)(6) 2017.Livanova (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication with the customer, livanova (b)(4) learned that air was delivered to the patient.The facility does not offer neurosurgery so the patient was sent to another hospital where he passed.The customer does not know why air was in the brain.The only anomaly identified was the slow turning of the pump but the facility was not able to confirm if this was the cause, as the air could have come from the other side as well.The device was sequestered following the event and was returned to service following maintenance from the livanova field service representative.The speed potentiometer replaced by the service representative during the on-site visit has been returned to sorin group usa, inc for investigation.Visual inspection did not identify any abnormalities or defects.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S3 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich,
• 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: 6609892
• MDR Text Key: 76585737
• Report Number: 9611109-2017-00400
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950990
• 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: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-60-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2003
• 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
• Patient Age: 51 YR