BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE DETECTOR SENSOR

    MDR report key: 14307024 · Received May 6, 2022

    Report

    Report Number
    9611109-2022-00216
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 5, 2022
    Report Date
    January 19, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KRL
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN NEW (B)(6). THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT A NEW BUBBLE SENSOR WAS ORDERED. NO ADDITIONAL INFORMATION REGARDING THE EXACT MALFUNCTION OF THE SENSOR COULD BE RETRIEVED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT ABOUT A BUBBLE DETECTOR NOT WORKING. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION ABOUT THE ISSUE WAS MADE AVAILABLE DUE TO IMPOSSIBILITY TO CONTACT CUSTOMER VIA PROVIDED CONTACTS. THROUGH FOLLOW UP, LIVANOVA WAS INFORMED A NEW BUBBLE SENSOR WAS INSTALLED AND THE UNIT WAS TESTED. NO DEVIATIONS WERE FOUND WHEN USING THE NEW BUBBLE SENSOR. THE NEW BUBBLE SENSOR WAS PUT IN SERVICE AND THE ENTIRE S5 WAS RETURNED TO THE CUSTOMER IN ITS EXPECTED FUNCTION. THE ANALYSIS OF THE COMPLAINTS DATABASE REVEALED THAT NO OTHER COMPLAINT ASSOCIATED TO THE COMPLAINED S5 CONSOLE WAS SUBMITTED. THE MOST PROBABLE ROOT CAUSE WAS A DEFECTIVE BUBBLE SENSOR. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED REPORT OF A BUBBLE DETECTOR SENSOR NOT WORKING DURING A PROCEDURE. NO FURTHER INFORMATION WERE PROVIDED. A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED THUS THIS EVENT IS CONSIDERED REPORTABLE AS PER CONSERVATIVE APPROACH. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436908 BUBBLE DETECTOR SENSOR MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL LIVANOVA DEUTSCHLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown