BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE DETECTOR SENSOR

    MDR report key: 17323000 · Received July 14, 2023

    Report

    Report Number
    9611109-2023-00330
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 13, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KRL
    UDI-DI
    04033817900573
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE SENSOR REACTED EVEN THOUGH THERE WAS NO AIR BUBBLES. IN CASE OF BUBBLE SENSOR TRIGGERING FALSE BUBBLE ALARMS (OVER-SENSING ISSUE), THE PUMP IS STOPPED BY THE BUBBLE ALARM EVEN IF NO AIR IS PRESENT IN THE MONITORED LINE. IN SUCH SITUATIONS, THE ALARM CAN ALWAYS BE CLEARED/OVERRIDDEN BY USER, ONCE THE LINE IS VERIFIED TO BE FREE OF AIR, AND THE PERFUSION CAN BE EASILY RESTARTED. THUS, IT IS UNLIKELY THAT A FALSE BUBBLE ALARM WILL RESULT IN SERIOUS INJURY. BASED ON THE ABOVE RATIONALE, THE EVENT HAS BEEN RE-ASSESSED AS NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN KURUME, JAPAN. THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, A NEW BUBBLE DETECTOR SENSOR WILL BE SHIPPED TO THE CUSTOMER. LIVANOVA INITIATED AN INVESTIGATION. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR MALFUNCTIONED DURING PRIMING. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699435 BUBBLE DETECTOR SENSOR MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL LIVANOVA DEUTSCHLAND 23-07-40 04033817900573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown