BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOLOCK¿ PORT

    MDR report key: 20031105 · Received August 22, 2024

    Report

    Report Number
    9617594-2024-01171
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 21, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00887709057005
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - (B)(6). THE COMPLAINT OF DISCONNECTION / LOOSE CONNECTION ON ITEM CL2100 CANNOT BE CONFIRMED. SINCE 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 PROBABLE CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REPORT (DHR) FOR LOT#5941166 WAS REVIEWED, AND NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED CONDITION ON THE COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A CHEMOLOCK¿ PORT WHERE THE CUSTOMER REPORTED THAT IT WAS DISCONNECTING FROM THE CHEMO LINE. THE CHEMO APPEARS TO HAVE SPILLED AND THE LINE WAS CLAMPED AND PUMPED WAS PAUSED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND THERE WAS UNKNOWN HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940911 CHEMOLOCK¿ PORT CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5941166 00887709057005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown