BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE DETECTOR

    MDR report key: 14021328 · Received April 6, 2022

    Report

    Report Number
    9611109-2022-00153
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 6, 2022
    Report Date
    April 6, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KRL
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. LIVANOVA (B)(4) MANUFACTURES THE BUBBLE SENSOR. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA PERFORMED ATTEMPT TO RETRIEVE ADDITIONAL INFORMATION TO CLARIFY THE MALFUNCTION OF THE THREE (3) BUBBLE SENSORS. NO REPLY HAS BEEN RECEIVED YET AND THE SERIAL NUMBERS ARE UNKNOWN. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER LIVANOVA LEARNED THAT THE CUSTOMER SCRAPPED THE BUBBLE SENSOR SO NO SERIAL NUMBER CAN BE PROVIDED.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 (B)(4) RECEIVED A REPORT THAT THREE (3) BUBBLE SENSORS ARE DEFECTIVE. THE ISSUE WAS IDENTIFIED DURING PRIMING. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NUMBERS ARE UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899757 BUBBLE DETECTOR MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL LIVANOVA DEUTSCHLAND 23-07-55

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown