BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED CENTRAL LINE TRANSDUCER SET

    MDR report key: 20614608 · Received November 5, 2024

    Report

    Report Number
    9617594-2024-01564
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    September 22, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD NOT BE CONFIRMED. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. A DEVICE HISTORY REVIEW (DHR) LOT # REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    D AND G TAB. THE PRODUCT INFORMATION IS UNKNOWN, RELATED DEVICE 510K AND PRODUCT CODE WERE USED: K061573, DRS, TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR. E TAB - COMPLETE INITIAL REPORTER INFORMATION WAS NOT PROVIDED. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING A UNSPECIFIED CENTRAL LINE TRANSDUCER SET - U3 THAT EXPERIENCED SEPARATION DURING USE. THE REPORTER STATED THAT " ICU MEDICAL TRANSPAC CVC TRANSDUCER KIT SNAPPED AT PORT. NO LOT NUMBER OR PHOTO." THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THE PRODUCT WAS CONTAMINATED. NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT. THE TIME OF EVENT WAS 9PM. IT BECAME AWARE OF THE ISSUE WHEN CHECKING THE CENTRAL LINE SET - NOTICE SET DETACHED AT 3 WAY TAP SECTION. A NORMAL SALINE WAS USED WITH THE PRODUCT. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE DATA WAS COMMUNICATED THROUGH "SATFF CONTACTED ME TO LET ME KNOW ISSUE HAD ARISEN. DATIX COMPLETED 843155". THERE WAS PATIENT INVOLVEMENT AND DELAY IN THERAPY. NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461790 UNSPECIFIED CENTRAL LINE TRANSDUCER SET TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown