BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE DETECTOR SENSOR

    MDR report key: 14711540 · Received June 16, 2022

    Report

    Report Number
    9611109-2022-00303
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 16, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KRL
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 (B)(6). LIVANOVA ATTEMPTED TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER TO CLARIFY THE MALFUNCTION AND NO RESPONSE HAS BEEN RECEIVED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA ATTEMPTED TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER TO CLARIFY THE MALFUNCTION AND NO RESPONSE HAS BEEN RECEIVED. HOWEVER, LIVANOVA TECHNICIAN SUGGESTED TO CUSTOMER THE REPLACEMENT FOR INVOLVED SENSOR. COMPLAINTS DATABASE ANALYSIS ON S5 CONSOLE WHICH THE COMPLAINED BUBBLE SENSOR WAS USED ON (SERIAL NUMBER (B)(6)) REVEALED NO EVENT OF BUBBLE SENSOR MALFUNCTION SINCE MACHINE INSTALLATION IN 2012. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED REPORT THAT A BUBBLE SENSOR DID NOT WORK DURING SETUP. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204065 BUBBLE DETECTOR SENSOR MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL LIVANOVA DEUTSCHLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown