BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE SENSOR DETECTOR

    MDR report key: 16395933 · Received February 17, 2023

    Report

    Report Number
    9611109-2023-00073
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 20, 2023
    Report Date
    February 17, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KRL
    PMA / PMN Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN TRENTO, ITALY. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW-UP COMMUNICATION WITH LIVANOVA FIELD SERVICE REPRESENTATIVE, IT WAS CLARIFIED THAT THE SENSOR WAS NOT RECOGNIZED BY THE S5 UNIT. THEREFORE, THE ISSUE IS ALWAYS DETECTABLE AS SOON AS THE SENSOR IS PLUGGED IN. THUS, THERE IS UNLIKELY POSSIBILITY TO CAUSE DEATH OR SERIOUS INJURY. THE EVENT HAS BEEN REASSESSED AS NOT REPORTABLE. LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE: BUBBLE SENSOR WAS NOT RECOGNIZED BY THE S5 CONSOLE. IN ORDER TO FIX THE ISSUE, BOTH BUBBLE SENSOR AND BUBBLE MODULE WERE REPLACED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO SIMILAR EVENT ON THIS DEVICE OCCURRED SINCE ITS INSTALLATION IN 2012. ROOT CAUSE OF THE REPORTED ISSUE COULD BE TRACED BACK TO FAULTY BUBBLE SENSOR AND MODULE MOST LIKELY DUE TO WEARING OF THE PARTS.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR WAS DEFECTIVE. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT BUBBLE SENSOR DID NOT DETECT AIR BUBBLE. 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
    137063 BUBBLE SENSOR DETECTOR MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL LIVANOVA DEUTSCHLAND 23-07-50

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown