BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINNING SPIROS CLOSED MALE LUER

    MDR report key: 9818280 · Received March 10, 2020

    Report

    Report Number
    MW5093665
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    March 6, 2020
    Report Date
    March 6, 2020
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    HOSPITAL PHARMACY HAS STARTED USING CHEMO CLAVE CLOSED SYSTEM TRANSFER DEVICE PRODUCTS (SPINNING SPIROS) FOR PHARMACY AND RN SAFETY W/ CHEMOTHERAPY PREPARATION AND ADMIN. WE HAVE HAD SEVERAL PROBLEMS W/ VARIOUS PARTS OF THESE SYSTEMS FROM ICU MEDICAL INC: LEAKING, BREAKING, FALLING OFF THE SYRINGE, ETC. WE HAVE REPORTED EACH TO THE MFR VIA THE ICU MEDICAL REP. I REPORTED A MALFUNCTION WITH THE SPINNING SPIROS WHICH OCCURRED TO MFR. FLUDARABINE IV SYRINGE AND TACROLIMUS IVPB PREPARED FOR MULTIPLE DIFFERENT PT AND DELIVERED TO UNIT. RN HAD JUST BEGUN SETUP, BUT DID NOT BEGIN ANY INFUSION, AND CAME TO PHARMACIST W/ BROKEN SPINNING SPIROS (CRACKED AT SEAM) OR FALLEN OFF THE SYRINGE OR FALLEN OFF THE TUBING EVEN AFTER TECH AND PHARMACISTS HAVE DOUBLE CHECKED THEY WERE SECURED PRIOR TO DELIVERY. THESE CLOSED SYSTEMS ARE SUPPOSED TO AID W/ SAFETY AND DECREASE RISK OF EXPOSURE TO HAZARDOUS MEDICATIONS. HOWEVER, WHEN THE LEAK, CRACK AND BREAK OR FALL OFF WHEN ABOUT TO INFUSE, THEY ARE PUTTING ASSOCIATES AND EVENT PT AT RISK. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277538 SPINNING SPIROS CLOSED MALE LUER SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL INC. 44935698
    277539 RED CAP SYRINGE, PISTON FMF ICU MEDICAL INC. 4549835

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization