BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 11705900 · Received April 22, 2021

    Report

    Report Number
    11705900
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 14, 2021
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRISET TUBING BROKE OFF OF ICU MEDICAL, INC. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® DURING VEST TREATMENT (HIGH-FREQUENCY CHEST WALL OSCILLATION). PATIENT WAS AGITATED AND THRASHING AROUND IN BED. TUBING BECAME DISLODGED FROM TRISET AND BLOOD BACKED UP INTO TUBING AND ONTO BED LINENS. PATIENT PAIN PUMP AND FLUIDS HAD TO BE DISCONNECTED AND NEW MEDS/TUBING HAD TO BE OBTAINED. ALL CONNECTIONS WERE HY-TAPED ON SET. IT WAS THE TUBING ITSELF THAT BROKE OFF FROM THE TRISET. INITIAL INSPECTIONS SUGGEST THAT THERE WAS IMPROPER SOLVENT ALLOWING THE EXTENSION TO DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604138 ICU MEDICAL STOPCOCK, I.V. SET FMG ICU MEDICAL, INC. A1141

    Patients

    Seq Age Sex Outcome Treatment
    1 1825 DA