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

Model Number 10-85-00

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The representative livanova field service representative who identified the issue traced the failure to a defective motor endstage board.The board was replaced and no further failures were noted.The device was tested and placed back into service.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.Evaluated on site by livanova technician.

Event Description

Livanova (b)(4) received a report that s5 double head pump did not give a audio alarm when the device was turned the direction.This issue was identified by a livanova field service representative during routine maintenance.There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).The replaced board was returned to livanova (b)(4) for detailed investigation.The reported issue was reproduced during testing and the investigation identified the cause to be a faulty buzzer on the board.

• Brand Name: S5 DOUBLE HEAD 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: 6595978
• MDR Text Key: 76147907
• Report Number: 9611109-2017-00380
• 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: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2012
• 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