BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE SENSOR DETECTOR

    MDR report key: 16396048 · Received February 17, 2023

    Report

    Report Number
    9611109-2023-00074
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 20, 2023
    Report Date
    April 26, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KRL
    UDI-DI
    04033817900597
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE SENSOR DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE DEVICE STOPPED SENSING. 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

    AS PER FIELD SERVICE TECHNICIAN NOTES, A NEW BUBBLE SENSOR HAS BEEN SENT TO THE CUSTOMER WHO WILL BE REPLACING IT THEMSELVES. BASED ON ALL THE ABOVE FACTS AND SIMILAR EVENT REPORTED BY OTHER CUSTOMERS, THE ROOT CAUSE OF THE REPORTED MALFUNCTION IS TRACED BACK TO A DEFECTIVE BUBBLE SENSOR. MOST LIKELY, A DEFECTIVE BUBBLE SENSOR CABLE CAUSED THE REPORTED EVENT. 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 DEUTSCHLAND RECEIVED A REPORT THAT A BUBBLE SENSOR DETECTOR WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166892 BUBBLE SENSOR DETECTOR MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL LIVANOVA DEUTSCHLAND 23-07-50 04033817900597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown