BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 20048389 · Received August 23, 2024

    Report

    Report Number
    20048389
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "RN NOTED THAT THE ANTI-SIPHON VALVE WAS LEAKING ONTO THE BED. EDUCATOR WAS BROUGHT IN TO ASSESS. ANTI-SIPHON VALVE WAS REMOVED. VALVE ITSELF LOOKED INTACT BUT WAS LEAKING. PER [REDACTED NAME]: I HAPPENED TO BE CALLED INTO A ROOM WHEN THE BEDSIDE NURSE HAD NOTED THAT AN ANTI-SIPHON VALVE ON HER LIPID INFUSION WAS LEAKING. THE ANTI-SIPHON VALVE WAS REMOVED, AND I PERSONALLY ATTACHED A SALINE FLUSH TO CHECK AND SEE IF IT WAS STILL LEAKING AND IT WAS. I NOTICED IT WAS LEAKING WHERE IT WAS CONNECTED TO MY SALINE SYRINGE SO I REMOVED IT AND REPLACED IT AGAIN ALSO ENSURING IT WAS TIGHT SO THAT I COULD BE POSITIVE IT WASN¿T USER ERROR. IT CONTINUED TO LEAK. THE NURSE STATED THAT SHE HAD NOT NOTICED IT LEAKING PRIOR TO THIS. I THEN REMOVED A NEW ANTI-SIPHON VALVE FROM A PACKAGE AND CHECKED THAT WITH THE SALINE SYRINGE AND THERE WAS NO LEAKING." MANUFACTURER RESPONSE FOR ANTI SIPHON VALVE, ANTI SIPHON VALVE (PER SITE REPORTER), [REDACTED DATE] SAMPLE PICKED UP AND EMAIL SENT TO ICU MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364243 ICU MEDICAL STOPCOCK, I.V. SET FMG ICU MEDICAL, INC. B6013 14017965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose