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

Model Number 23-45-00

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the s5 bubble sensor module.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).A (b)(4) field service representative shipped a new bubble sensor to the customer.The customer plans to install the new bubble sensor on their own.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

(b)(4) received a report that the s5 bubble sensor module alarmed during a procedure when no bubble was present, and that the 1/4" bubble sensor was not recognized.There was no report of patient injury.

Manufacturer Narrative

This is a follow up to the initial mdr submitted.The technician tested the bubble sensor on the s5 test bed and encountered constant bubble alarms whether bubbles were present or not, the reported failure was confirmed.The described error could be reproduced; cause of the fault; 1/4´´ bubble sensor is defect.The root-cause was determined to be sensor out of calibration (ceramic plate is broken).The bubble sensor will be scrapped.Correction to mfr site to reflect changes to manufacturers name.

• Brand Name: S5 BUBBLE SENSOR MODULE
• 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,
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6580067
• MDR Text Key: 75626767
• Report Number: 9611109-2017-00367
• Device Sequence Number: 1
• Product Code: KRL
• 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: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-45-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• 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