BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 BUBBLE DETECTOR SENSOR 3/16''

    MDR report key: 13599407 · Received February 25, 2022

    Report

    Report Number
    9611109-2022-00085
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 25, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KRL
    UDI-DI
    04033817900603
    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. THE S5 BUBBLE DETECTOR SENSOR 3/16'' IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO S5 BUBBLE DETECTOR SENSOR 3/8'', WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K955152). LIVANOVA (B)(4) MANUFACTURES THE S5 BUBBLE DETECTOR SENSOR 3/16''. THE INCIDENT OCCURRED IN (B)(6). 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

    H.10: THROUGH FOLLOW UP COMMUNICATION WITH THE SERVICE ENGINEER, IT WAS LEARNED THAT THE BUBBLE SENSOR MAY HAVE HAD A BROKEN CABLE. HOWEVER, THIS COULD NOT BE CONFIRMED AND THIS CASE IS CONSERVATIVELY CONSIDERED AS REPORTABLE EVENT. NO TREND OR PATTERN HAS BEEN IDENTIFIED FOR BUBBLE SENSOR MALFUNCTION. NO OTHER INFORMATION HAS BEEN MADE AVAILABLE ON THIS SPECIFIC CASE AND THE EXACT MALFUNCTION OF THE BUBBLE SENSOR COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H.10: NO OTHER INFORMATION HAS BEEN MADE AVAILABLE ON THIS SPECIFIC CASE AND THE MALFUNCTION OF THE BUBBLE SENSOR COULD NOT BE DETERMINED. A QUOTATION TO CUSTOMER FOR A NEW BUBBLE SENSOR HAS BEEN ISSUED AND IS STILL PENDING APPROVAL. THE DEFECTIVE BUBBLE SENSOR WAS MANUFACTURED IN 2016 AND NO OTHER COMPLAINTS WERE SUBMITTED IN THE PAST. 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 A BUBBLE SENSOR 3/16'' WAS FOUND TO BE DEFECTIVE DURING PRIMING. NO ADDITIONAL DETAILS WERE PROVIDED.THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488689 S5 BUBBLE DETECTOR SENSOR 3/16'' MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL LIVANOVA DEUTSCHLAND 23-07-55 04033817900603

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown