BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 10939848 · Received December 3, 2020

    Report

    Report Number
    10939848
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 21, 2020
    Report Date
    December 1, 2020
    Manufacturer
    ICU MEDICAL INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BUSULFAN WAS WASTED AND HAD TO BE REMADE DUE TO LEAK ON THE UNIT. NURSE ASKED PHARMACY TO REMAKE MEDICATION DUE TO LEAK. I CALLED NURSE TO CLARIFY DETAILS. SOUNDS LIKE AFTER PRIMING ON THE UNIT, MEDICATION WAS FOUND TO BE LEAKING FROM THE SPIROS (ICUMEDICAL SPINNING SPIROS CLOSED MALE LUER, RED CAP, LOT 4991021). PHARMACY REMADE AND SENT NEW BAG TO UNIT WITH A DIFFERENT SPIROS LOT NUMBER. UPON FURTHER INVESTIGATION AFTER SPEAKING TO NURSE, ITS SOUNDS LIKE NURSE DID NOT PUT ON A C CLIP WHILE PRIMING, WHICH LED TO LEAK OUT OF SPIROS. NURSE SAID THAT SHE WAS TOLD IT WAS OPTIONAL TO HAVE C CLIP. NOT SURE IF THERE WAS PREVIOUS COMMUNICATION REGARDING NOT NEEDING C CLIP, BUT THERE NEEDS TO BE FURTHER NURSING EDUCATION NOW REGARDING CIRCLE PRIMING AND C CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403470 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL INC CH2000S-C 4991021

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA